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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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ASHER KASSEL
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Regulation Number
870.1025
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Classification Product Code
MHX
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More FDA Info for this Product Code
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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