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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 K931296
Device Name PACEART CARDIOPHONE
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  
Subsequent Product Codes
DTG   KRE  
Date Received03/30/1993
Decision Date 10/01/1993
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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