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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K915153
Device Name ESCORT-LINK ARRHYTHMIA OPTION 23L
Applicant
MEDICAL DATA ELECTRONICS
12720 WENTWORTH ST.
ARLETA,  CA  91331
Applicant Contact JIM ROOKS
Correspondent
MEDICAL DATA ELECTRONICS
12720 WENTWORTH ST.
ARLETA,  CA  91331
Correspondent Contact JIM ROOKS
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/14/1991
Decision Date 04/27/1992
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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