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FDA 510(k) Application Details - K012924
Device Classification Name
Vaporizer, Anesthesia, Non-Heated
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510(K) Number
K012924
Device Name
Vaporizer, Anesthesia, Non-Heated
Applicant
DATEX-OHMEDA, INC.
P.O. BOX 7550
MADISON, WI 53707-7550 US
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BILL EXNER
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Regulation Number
868.5880
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Classification Product Code
CAD
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Date Received
08/31/2001
Decision Date
01/30/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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