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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K160112
Device Name Besmed PEEP Valve
Applicant
BESMED HEALTH BUSINESS CORP.
NO.5, LANE 116, WU-KONG 2ND RD
NEW TAIPEI CITY,  TW
Applicant Contact ERIC LI
Correspondent
BESMED HEALTH BUSINESS CORP.
NO.5, LANE 116, WU-KONG 2ND RD
NEW TAIPEI CITY,  TW
Correspondent Contact PAUL DRYDEN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received01/19/2016
Decision Date 04/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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