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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
FLUKE BIOMEDICAL
6045 cochran rd.
solon,  OH  44139
Original Contact john nelson
Regulation Number870.2300
Classification Product Code
DRT  
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
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