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FDA 510(k) Application Details - K022650
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K022650
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
APEX MEDICAL CORP.
10TH FL., NO. 31, LANE 169,
KANG NING ST.
SHI-CHIH, TAIPEI HSIEN TW
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Contact
ALAN CHANG
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Regulation Number
868.5905
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Classification Product Code
BZD
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More FDA Info for this Product Code
Date Received
08/09/2002
Decision Date
02/04/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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