FDA 510(k) Application Details - K133014

Device Classification Name Electrocardiograph,Ambulatory(Without Analysis)

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510(K) Number K133014
Device Name Electrocardiograph,Ambulatory(Without Analysis)
Applicant DIAGNOSTIC MONITORING SOFTWARE
290 Kingsbury Grade # 3
Stateline, NV 89449 US
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Contact WILLIAM PARSONS
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Regulation Number 870.2800

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Classification Product Code MWJ
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Date Received 09/25/2013
Decision Date 05/19/2014
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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