FDA 510(k) Application Details - K111296

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K111296
Device Name System,Network And Communication,Physiological Monitors
Applicant ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 MILL ROAD
CHELMSFORD, MA 01824-4105 US
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Contact CHARLES W KOLIFRATH
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 05/09/2011
Decision Date 10/27/2011
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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