|
Device |
thermometer, electronic, clinical |
Product Code | FLL |
Regulation Number |
880.2910
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AION BIOSYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALICN MEDICAL SHENZHEN, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ALICN MEDICAL SHENZHEN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALICN MEDICAL SHENZHEN,INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANDON HEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOLAND TECHNOLOGY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOLAND TECHNOLOGY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BLUE SPARK TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BODYCAP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BROADMASTER BIOTECH, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CIRCA SCIENTIFIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CIRCA SCIENTIFIC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONMO ELECTRONIC COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTEC MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEROYAL INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN E-TEST TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN XINTAI INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FAMIDOC TECHNOLOGY COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIAB SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANDONG GENIAL TECHNOLOGY CO., LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG GENIAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
HADLEIGH HEALTH TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU QINGYUAN MEDICAL EQUIPMENT TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTH & LIFE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEITAIDA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HETAIDA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HONSUN (NANTONG) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUAIAN ZHONGXIN PACKING MATERIAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUBDIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNAN HONGGAO ELECTRONIC TECHNOLOFY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IWEECARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIAXING SHANGJIA INTELLIGENCE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JKH HEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JKH USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOYTECH HEALTHCARE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOYTECH HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JOYTECH HEALTHCARE CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KANGFU MEDICAL EQUIPMENT FACTORY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KANGZHAN COMMUNICATION ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAZ USA, INC., A HELEN OF TROY COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SCIENCE TECHNOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LONGNAN RENZHONG MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MASIMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
METKO MEDIKAL VE TTBBI CIHAZLAR D1S TICARET LTD. STI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROLIFE INTELLECTUAL PROPERTY GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHOENIX INNOVATIVE HEALTHCARE MANUFACTURERS PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PUTIAN HANJIANG HUAFENG PLASTIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QINGDAO YASEE MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SENSATRONIC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG BITTEL INTELLIGENT TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHEN ZHEN RONG FENG TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CALIBEUR INDUSTRIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN COMBEI TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN ENVISEN INDUSTRY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN FINICARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JUMPER MEDICAL EQUIPMENT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JUZHONG TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN PANGO ELECTRONIC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN SONIDA DIGITAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN URION TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN XUNWEI INDUSTRIAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YI FANG BLISTER PACKAGING CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YOLANDA TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SICHUAN YOUKEDE MEDICAL EQUIPMENT CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMART TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU MELODICARE MEDICAL TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
T&R BIOFAB CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIDOC TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRULY INSTRUMENT LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TYTO CARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNI-TREND TECHNOLOGY (CHINA) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNI-TREND TECHNOLOGY(CHINA) CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELLVII INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WENZHOU YOSUN MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
XIAMEN ANTS BRO TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
XIAMEN INTRETECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YIBIN JUNXIN ELECTRONICS TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG RONGSHENG INDUSTRIAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHONGSHAN JINLI ELECTRONIC WEIGHING EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUHAI YUEJA MEDICAL DEVICE TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUZHOU GOLDENHOT MEDICAL TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|