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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 K992674
Device Name HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
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
MHX  
Date Received08/10/1999
Decision Date 11/08/1999
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
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