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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 K110429
Device Name PROSIM 4, PROSIM 6, PROSIM 8
Applicant
Fluke Biomedical
6045 Cochran Rd.
Cleveland,  OH  44139
Applicant Contact JOHN NELSON
Correspondent
Fluke Biomedical
6045 Cochran Rd.
Cleveland,  OH  44139
Correspondent Contact JOHN NELSON
Regulation Number870.2300
Classification Product Code
DRT  
Date Received02/15/2011
Decision Date 09/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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