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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K153184
Device Name Caremed Reusable & Disposable SPO2 Sensors
Applicant
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
ZONE B, 3/F, 11 BUILDING, HEBEI INDUSTRIAL AREA,
LONGHUA OFFICE, LONGHUA NEW D
SHENZHEN,  CN 518021
Applicant Contact XINLIN XIAO
Correspondent
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
ZONE B, 3/F, 11 BUILDING, HEBEI INDUSTRIAL AREA,
LONGHUA OFFICE, LONGHUA NEW D
SHENZHEN,  CN 518021
Correspondent Contact XINLIN XIAO
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/03/2015
Decision Date 01/04/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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