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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 K981376
Device Name HEWLETT-PACKARD M1205A VIRIDIA 24 CT
Applicant
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact DAVID OSBORN
Correspondent
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact DAVID OSBORN
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/16/1998
Decision Date 01/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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