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FDA 510(k) Application Details - K071805
Device Classification Name
Detector And Alarm, Arrhythmia
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510(K) Number
K071805
Device Name
Detector And Alarm, Arrhythmia
Applicant
DATASCOPE CORP.
800 MACARTHUR BLVD.
MAHWAH, NJ 07430-0619 US
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Contact
KATHLEEN KRAMER
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Regulation Number
870.1025
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Classification Product Code
DSI
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More FDA Info for this Product Code
Date Received
07/02/2007
Decision Date
09/25/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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