|
Device |
system, measurement, blood-pressure, non-invasive |
Product Code | DXN |
Regulation Number |
870.1130
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
A&D COMPANY, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
A&D COMPANY, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACCURATE MEDITECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALICN MEDICAL (SHENZHEN), INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALICN MEDICAL SHENZHEN, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALICN MEDICAL SHENZHEN,INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ANDON HEALTH CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANDON HEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ATCOR MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVICHE SHANDONG MEDICAL TECHNOLOGY CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVITA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOLAND TECHNOLOGY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARETAKER MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARETAKER MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CNSYSTEMS MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONMO ELECTRONIC COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTEC MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN E-TEST TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EDAN INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFE SCIENCES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFESCIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
FAMIDOC TECHNOLOGY COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GMC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG GENIAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
HEALTH & LIFE CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTH & LIFE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEALTH & LIFE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HETAIDA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
I.E.M. INDUSTRIELLE ENTWICKLUNG AND MEDIZINTECHNIK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INBODY CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INBODY 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
|
JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOYTECH HEALTHCARE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
JOYTECH HEALTHCARE CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LD TECHNOLOGY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIVEMETRIC (MEDICAL) S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LOTUSNINE MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIANA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDITECH LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC CARE MANAGEMENT SERVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROLIFE INTELLECTUAL PROPERTY GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
NANOWEAR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMRON HEALTHCARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PURSUANT HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PYRAMES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QARDIO INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QINGDAO YASEE MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RGB MEDICAL DEVICES SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RUDOLF RIESTER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SECA GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CHANGKUN TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN FINICARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN GOODLYMED TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN HBCARE TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN HINGMED MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JAMR MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JAMR TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN JAMR TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MED-LINK ELECTRONICS TECH CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN PANGO ELECTRONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN URION TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN VIATOM TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN YOLANDA TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YOLANDA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YUEZHONGXING TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIDOC TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIWAN SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRULY INSTRUMENT LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITA-COURSE TECHNOLOGIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WENZHOU YOSUN MEDICAL TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEONY (SHENZHEN) TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
XIAMEN ANTS BRO TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YA HORNG ELECTRONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YIBIN JUNXIN ELECTRONICS TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUHAI YUEJA MEDICAL DEVICE TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|