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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 K993383
Device Name HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
Applicant
Hewlett-Packard GmbH
Herrenberger St. 110-140
Boeblingen,  DE 71034
Applicant Contact EGON PFEIL
Correspondent
Hewlett-Packard GmbH
Herrenberger St. 110-140
Boeblingen,  DE 71034
Correspondent Contact EGON PFEIL
Regulation Number870.1025
Classification Product Code
DSI  
Date Received10/08/1999
Decision Date 02/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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