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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K880283
Device Name PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS
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 Number870.2920
Classification Product Code
DXH  
Date Received01/22/1988
Decision Date 03/09/1988
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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