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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 K121722
Device Name ESA620 ELECTRICAL SAFETY ANALYZER
Applicant
FLUKE BIOMEDICAL
6045 COCHRAN RD.
SOLON,  OH  44139
Applicant Contact JOHN NELSON
Correspondent
FLUKE BIOMEDICAL
6045 COCHRAN RD.
SOLON,  OH  44139
Correspondent Contact JOHN NELSON
Regulation Number870.2300
Classification Product Code
DRT  
Date Received06/12/2012
Decision Date 10/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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