The following data is part of a premarket notification filed by Hewlett-packard Gmbh with the FDA for Hewlett Apckard Series 50 Ob Tracevue Obstetrical Surveillance And Archiving System.
| Device ID | K970456 |
| 510k Number | K970456 |
| Device Name: | HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM |
| Classification | System, Monitoring, Perinatal |
| Applicant | HEWLETT-PACKARD GMBH SCHICKARD STRASSE 4 BOEBLINGEN Wuerttemberg, DE 71034 |
| Contact | Mike Hudon |
| Correspondent | Mike Hudon HEWLETT-PACKARD GMBH SCHICKARD STRASSE 4 BOEBLINGEN Wuerttemberg, DE 71034 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-06 |
| Decision Date | 1997-10-03 |
| Summary: | summary |