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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, Indirect
510(k) Number K915632
Device Name PACEART CPTS-86/12
Applicant
Paceart, Inc.
22 Riverview Dr.
Wayne,  NJ  07470
Applicant Contact MICHAEL BERGELSON
Correspondent
Paceart, Inc.
22 Riverview Dr.
Wayne,  NJ  07470
Correspondent Contact MICHAEL BERGELSON
Regulation Number870.3640
Classification Product Code
KRE  
Date Received12/17/1991
Decision Date 04/14/1992
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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