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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 K083656
Device Name APEX MEDICAL XT AUTO CPAP 9S-005200
Applicant
Apex Medical Corp.
# 9, Minsheng St.
Tucheng City, Taipei County,  TW 236
Applicant Contact ALAN CHANG
Correspondent
Apex Medical Corp.
# 9, Minsheng St.
Tucheng City, Taipei County,  TW 236
Correspondent Contact ALAN CHANG
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/10/2008
Decision Date 04/22/2009
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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