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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 K022650
Device Name APEX MEDICAL CPAP RT 21XX
Applicant
APEX MEDICAL CORP.
10TH FL., NO. 31, LANE 169,
KANG NING ST.
SHI-CHIH, TAIPEI HSIEN,  TW
Applicant Contact ALAN CHANG
Correspondent
APEX MEDICAL CORP.
10TH FL., NO. 31, LANE 169,
KANG NING ST.
SHI-CHIH, TAIPEI HSIEN,  TW
Correspondent Contact ALAN CHANG
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/09/2002
Decision Date 02/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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