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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 Bldg., 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 Bldg., 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
Predetermined Change
Control Plan Authorized		 No
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