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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K954351
Device Name SERIES 50XM
Applicant
HEWLETT-PACKARD GMBH
SCHICKARD STRASSE 4
BOEBLINGEN
WUERTTEMBERG,  DE 71034
Applicant Contact MONICA FERRANTE
Correspondent
HEWLETT-PACKARD GMBH
SCHICKARD STRASSE 4
BOEBLINGEN
WUERTTEMBERG,  DE 71034
Correspondent Contact MONICA FERRANTE
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
DXN  
Date Received09/18/1995
Decision Date 03/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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