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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.
# 9, Min Sheng St., Tu-Cheng,
New Taipei City,  TW 23679
Applicant Contact ALAN CHANG
Correspondent
Apex Medical Corp.
# 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
Predetermined Change
Control Plan Authorized		 No
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