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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K874447
Device Name DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC
Applicant
Medac, Inc.
7451 SW Coho Ct.
Tualatin,  OR  97062
Applicant Contact BOB BOONSTRA
Correspondent
Medac, Inc.
7451 SW Coho Ct.
Tualatin,  OR  97062
Correspondent Contact BOB BOONSTRA
Regulation Number870.5550
Classification Product Code
DRO  
Date Received10/28/1987
Decision Date 01/27/1988
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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