FDA 510(k) Application Details - K964624

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K964624
Device Name Detector And Alarm, Arrhythmia
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact ROBERT W BECKER
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 11/12/1996
Decision Date 09/11/1997
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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