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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 K012336
Device Name MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
Applicant
Medical Data Electronics
12723 Wentworth St.
Arleta,  CA  91331
Applicant Contact GREGORY R ALKIRE
Correspondent
Medical Data Electronics
12723 Wentworth St.
Arleta,  CA  91331
Correspondent Contact GREGORY R ALKIRE
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/24/2001
Decision Date 10/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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