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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 K843547
Device Name PACE *AID MODEL 52
Applicant
Cardiac Resucitator Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact BRUCE HAGGAR
Correspondent
Cardiac Resucitator Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact BRUCE HAGGAR
Regulation Number870.5550
Classification Product Code
DRO  
Date Received09/10/1984
Decision Date 12/17/1984
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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