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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 K970456
Device Name HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
Applicant
Hewlett-Packard GmbH
Schickard Strasse 4
Boeblingen
Wuerttemberg,  DE 71034
Applicant Contact MIKE HUDON
Correspondent
Hewlett-Packard GmbH
Schickard Strasse 4
Boeblingen
Wuerttemberg,  DE 71034
Correspondent Contact MIKE HUDON
Regulation Number884.2740
Classification Product Code
HGM  
Date Received02/06/1997
Decision Date 10/03/1997
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
Predetermined Change
Control Plan Authorized		 No
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