Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-