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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 K120035
Device Name APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
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 Received01/04/2012
Decision Date 05/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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