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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 K141362
Device Name PULSE OXIMETER CMS50EW
Applicant
CONTEC MEDICAL SYSTEMS CO., LTD.
P.O. BOX 120-119
SHANGAI,  CN 200120
Applicant Contact Diana Hong
Correspondent
CONTEC MEDICAL SYSTEMS CO., LTD.
P.O. BOX 120-119
SHANGAI,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/23/2014
Decision Date 04/23/2015
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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