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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K141522
Device Name APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
Applicant
APEX MEDICAL CORP.
NO. 9, MIN SHENG ST., TU-CHENG,
NEW TAIPEI CITY,  TW 23679
Applicant Contact ALAN CHANG
Correspondent
APEX MEDICAL CORP.
NO. 9, MIN SHENG ST., TU-CHENG,
NEW TAIPEI CITY,  TW 23679
Correspondent Contact ALAN CHANG
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/09/2014
Decision Date 10/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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