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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K992411
Device Name ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
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 Number870.2300
Classification Product Code
DRT  
Subsequent Product Codes
DQA   DTE  
Date Received07/20/1999
Decision Date 08/18/1999
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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