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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K870622
Device Name HEART*AID 1000
Applicant
Cardiac Resucitator Corp.
12244 SW Garden Pl.
Portland,  OR  97223
Applicant Contact JOHN L KARPOWICZ
Correspondent
Cardiac Resucitator Corp.
12244 SW Garden Pl.
Portland,  OR  97223
Correspondent Contact JOHN L KARPOWICZ
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/12/1987
Decision Date 04/10/1987
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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