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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 K103174
Device Name APEX MEDICAL WIZARD SERIES CPAP MASK
Applicant
APEX MEDICAL CORP.
NO. 9, MINSHENG STREET
TUCHENG CITY, TAIPEI COUNTY,  TW 236
Applicant Contact ALAN CHANG
Correspondent
APEX MEDICAL CORP.
NO. 9, MINSHENG STREET
TUCHENG CITY, TAIPEI COUNTY,  TW 236
Correspondent Contact ALAN CHANG
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/27/2010
Decision Date 05/06/2011
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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