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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 K874319
Device Name MONITOR, ELECTROGRAPHIC
Applicant
Medac, Inc.
25115 SW Pkwy. Ave.
Wilsonville,  OR  97070
Applicant Contact ROBERT M BOONSTRA
Correspondent
Medac, Inc.
25115 SW Pkwy. Ave.
Wilsonville,  OR  97070
Correspondent Contact ROBERT M BOONSTRA
Regulation Number870.2300
Classification Product Code
DRT  
Date Received10/21/1987
Decision Date 03/07/1988
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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