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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, St Segment With Alarm
510(k) Number K982104
Device Name ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
Applicant
Medical Data Electronics
12720 Wentworth St.
Arleta,  CA  91331
Applicant Contact DAVID M TRUEBLOOD
Correspondent
Medical Data Electronics
12720 Wentworth St.
Arleta,  CA  91331
Correspondent Contact DAVID M TRUEBLOOD
Regulation Number870.1025
Classification Product Code
MLD  
Date Received06/15/1998
Decision Date 11/25/1998
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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