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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
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