|
Device |
oximeter |
Product Code | DQA |
Regulation Number |
870.2700
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AVITA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BELUN TECHNOLOGY COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOBEAT TECHNOLOGIES LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BODIMETRICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHRONISENSE MEDICAL, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COFOE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DONGGUAN LINGXIN TECHNOLOGIES CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMPATICA S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GABI SMARTCARE SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG GENIAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG LONG YAO ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANCOCK MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUIZHOU XIAOOU TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JKH USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LEADTEK RESEARCH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MASIMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
MOVANO INC. DBA MOVANO HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NONIN MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OWLET BABY CARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OXIWEAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S.L.P. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEMPULSE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN AEON TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN BRAV ELECTRONIC TECHNOLOGIES CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K191420 Reusable SpO2 Sensor
|
2. K200069 Disposable SpO2 Sensor
|
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CREATIVE INDUSTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN HEXIN ZONDAN MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MECUN MEDICAL SUPPLY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MERICONN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN NARIG BIO-MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN RAYSINTONE TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN SMALLSIGNAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN UPNMED EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN VIATOM TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN WITLEAF MEDICAL ELECTRONICS CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN YIMI LIFE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YIMI LIFE-TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIBEL HEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPRY HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER SUSTAINABILITY SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUREPULSE MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TAIWAN BIOPHOTONIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRUE WEARABLES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNIMED MEDICAL SUPPLIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VYVO TECHNOLOGY CORP.(VT) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WESPER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XINKANG MEDICAL INSTRUMENT CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|