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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K000854
Device Name VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
Applicant
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Applicant Contact DAVE OSBORN
Correspondent
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Correspondent Contact DAVE OSBORN
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSI   MLD  
Date Received03/16/2000
Decision Date 04/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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