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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 K885085
Device Name ERGOMED 840/ERGOMED 840L
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 Number870.2300
Classification Product Code
DRT  
Date Received12/09/1988
Decision Date 10/03/1989
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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