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FDA 510(k) Application Details - K080175
Device Classification Name
Gas-Machine, Anesthesia
More FDA Info for this Device
510(K) Number
K080175
Device Name
Gas-Machine, Anesthesia
Applicant
DATASCOPE CORP., PATIENT MONITORING DIVISION
800 MACARTHUR BLVD.
MAHWAH, NJ 07430-0619 US
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Contact
KATHLEEN KRAMER
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Regulation Number
868.5160
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Classification Product Code
BSZ
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More FDA Info for this Product Code
Date Received
01/24/2008
Decision Date
06/09/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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