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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 K150111
Device Name Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
Applicant
APEX MEDICAL CORP.
NO. 9, MIN SHENG ST.,
TU-CHENG DISTRICT
NEW TAIPEI COUNTY,  TW 23679
Applicant Contact Frank Lin
Correspondent
APEX MEDICAL CORP.
NO. 9, MIN SHENG ST.,
TU-CHENG DISTRICT
NEW TAIPEI COUNTY,  TW 23679
Correspondent Contact Frank Lin
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/20/2015
Decision Date 09/15/2015
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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