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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K852250
Device Name 595 ARRHYTHMIA MONITORING SYSTEM
Applicant
Burdick Corp.
15 Plumb St.
Miltoon,  WI  53563
Applicant Contact FRANCIS I DOMINY
Correspondent
Burdick Corp.
15 Plumb St.
Miltoon,  WI  53563
Correspondent Contact FRANCIS I DOMINY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received05/23/1985
Decision Date 05/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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