FDA 510(k) Application Details - K102174

Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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510(K) Number K102174
Device Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 MILL ROAD
CHELMSFORD, MA 01824-4105 US
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Contact PAUL DIAS
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Regulation Number 870.2300

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Classification Product Code DRT
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Date Received 08/02/2010
Decision Date 09/15/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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