FDA 510(k) Application Details - K062088

Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm

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510(K) Number K062088
Device Name Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant DIAGNOSTIC MONITORING SOFTWARE
292 KINGSBURY GRADE, #32
P.O. BOX 3109
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 MLO
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Date Received 07/24/2006
Decision Date 08/25/2006
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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