FDA 510(k) Application Details - K990563

Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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510(K) Number K990563
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact PENELOPE H GRECO
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 02/22/1999
Decision Date 03/19/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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