Caremed Reusable & Disposable SPO2 Sensors

Oximeter

SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Shenzhen Caremed Medical Technology Co., Ltd. with the FDA for Caremed Reusable & Disposable Spo2 Sensors.

Pre-market Notification Details

Device IDK153184
510k NumberK153184
Device Name:Caremed Reusable & Disposable SPO2 Sensors
ClassificationOximeter
Applicant SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. ZONE B, 3/F, 11 BUILDING, HEBEI INDUSTRIAL AREA, LONGHUA OFFICE, LONGHUA NEW D Shenzhen,  CN 518021
ContactXinlin Xiao
CorrespondentXinlin Xiao
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. ZONE B, 3/F, 11 BUILDING, HEBEI INDUSTRIAL AREA, LONGHUA OFFICE, LONGHUA NEW D Shenzhen,  CN 518021
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-03
Decision Date2017-01-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970758500173 K153184 000
06970758500166 K153184 000
06970758500159 K153184 000
06970758500029 K153184 000
06970758507691 K153184 000
06970758507707 K153184 000

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