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FDA 510(k) Application Details - K091927
Device Classification Name
Detector And Alarm, Arrhythmia
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510(K) Number
K091927
Device Name
Detector And Alarm, Arrhythmia
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN D 71034 DE
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Contact
ANDREAS SUCHI
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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
06/30/2009
Decision Date
11/03/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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