FDA 510(k) Application Details - K000563

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

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510(K) Number K000563
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant MENNEN MEDICAL LTD.
KIRYAT WEIZMANN SCIENCE PARK
P.O. BOX 102
REHOVOT 76100 IL
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Contact KENNETH RAICHMAN
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 02/22/2000
Decision Date 05/17/2000
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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