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FDA 510(k) Application Details - K022124
Device Classification Name
Meter, Peak Flow, Spirometry
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510(K) Number
K022124
Device Name
Meter, Peak Flow, Spirometry
Applicant
GALEMED CORP.
87, LI-GONG 2ND RD.,
WU-JIA, I-LAN 268 TW
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Contact
BRUCE KUO
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Regulation Number
868.1860
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Classification Product Code
BZH
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More FDA Info for this Product Code
Date Received
07/01/2002
Decision Date
04/03/2003
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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