FDA 510(k) Application Details - K031340

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

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510(K) Number K031340
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 04/28/2003
Decision Date 11/25/2003
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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