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FDA 510(k) Application Details - K062088
Device Classification Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
MLO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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