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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Pacemaker Generator Function
510(k) Number K780717
Device Name EXTERNAL TEST PULSE GENERATOR
Applicant
Vitatron Medical BV
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Vitatron Medical BV
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3630
Classification Product Code
DTC  
Date Received04/27/1978
Decision Date 06/30/1978
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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