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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 K954495
Device Name PACETRAK PLUS
Applicant
Universal Medical, Inc.
1760 Market St.
13th Floor
Philadelphia,  PA  19103
Applicant Contact DOUGLAS M LURIO
Correspondent
Universal Medical, Inc.
1760 Market St.
13th Floor
Philadelphia,  PA  19103
Correspondent Contact DOUGLAS M LURIO
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/27/1995
Decision Date 04/22/1996
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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