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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Magnet, Test, Pacemaker
510(k) Number K813153
Device Name TEST MAGNET
Applicant
Pacesetter Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pacesetter Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3690
Classification Product Code
DTG  
Date Received11/06/1981
Decision Date 12/02/1981
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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