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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 K902254
Device Name ESCORT MODEL 400T TELEMETRY ECG MONITOR
Applicant
Medical Data Electronics
12720 Wentworth St.
Arleta,  CA  91331
Applicant Contact CHIP HARLOW
Correspondent
Medical Data Electronics
12720 Wentworth St.
Arleta,  CA  91331
Correspondent Contact CHIP HARLOW
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/21/1990
Decision Date 07/27/1990
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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