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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 K993516
Device Name HP M2600A VIRIDIA TELEMETRY SYSTEM
Applicant
HEWLETT-PACKARD CO.
3000 MINUTEMAN ROAD, MS 0491
ANDOVER,  MA  01810 -1099
Applicant Contact DENISE HALEY
Correspondent
HEWLETT-PACKARD CO.
3000 MINUTEMAN ROAD, MS 0491
ANDOVER,  MA  01810 -1099
Correspondent Contact DENISE HALEY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received10/18/1999
Decision Date 11/08/1999
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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