FDA 510(k) Application Details - K030722

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

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510(K) Number K030722
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant MENNEN MEDICAL, INC.
P.O. BOX 102
REHOVOT 76100 IL
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Contact ASHER KASSEL
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 03/07/2003
Decision Date 02/26/2004
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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