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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 K843358
Device Name HEART-AID MODEL 80
Applicant
Cardiac Resucitator Corp.
25117 SW Pkwy.
Wilsonville,  OR  97070
Applicant Contact BRUCE HAGGAR
Correspondent
Cardiac Resucitator Corp.
25117 SW Pkwy.
Wilsonville,  OR  97070
Correspondent Contact BRUCE HAGGAR
Regulation Number870.5550
Classification Product Code
DRO  
Date Received08/27/1984
Decision Date 11/19/1984
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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