The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Ob Tracevue Obstetrical Information Management System With Release F.00.
| Device ID | K081203 |
| 510k Number | K081203 |
| Device Name: | OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 |
| Classification | System, Monitoring, Perinatal |
| Applicant | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 BOEBLINGEN Baden-wuerttemberg, DE D-71034 |
| Contact | Michael Asmalsky |
| Correspondent | Michael Asmalsky PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 BOEBLINGEN Baden-wuerttemberg, DE D-71034 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-28 |
| Decision Date | 2008-05-28 |
| Summary: | summary |