FDA 510(k) Application Details - K030931

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

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510(K) Number K030931
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant ANALOGIC CORP.
8 CENTENNIAL DR.
PEABODY, MA 01960 US
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Contact MARVIN ROSENBAUM
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 03/25/2003
Decision Date 05/09/2003
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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