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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 K882327
Device Name PACER SENSING ANALYZER (PSA 100)
Applicant
Oscor Medical Corp.
3816 Desoto Blvd.
P.O. Box 459
Palm Harbor,  FL  34683
Applicant Contact DE GRAAD
Correspondent
Oscor Medical Corp.
3816 Desoto Blvd.
P.O. Box 459
Palm Harbor,  FL  34683
Correspondent Contact DE GRAAD
Regulation Number870.3630
Classification Product Code
DTC  
Date Received06/06/1988
Decision Date 10/06/1988
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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