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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, cardiac (incl. cardiotachometer & rate alarm)
510(k) Number K121860
Model 4132046,4162180
Device Name ESA615
Original Applicant
6045 cochran rd.
solon,  OH  44139
Original Contact john nelson
Regulation Number870.2300
Classification Product Code
Date Received06/26/2012
Decision Date 01/25/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No