The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Philips Obtracevue Model Sw Rev. G.00.
| Device ID | K100420 |
| 510k Number | K100420 |
| Device Name: | PHILIPS OBTRACEVUE MODEL SW REV. G.00 |
| Classification | System, Monitoring, Perinatal |
| Applicant | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen, DE 71034 |
| Contact | Michael Asmalsky |
| Correspondent | Michael Asmalsky PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen, DE 71034 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-07-26 |
| Summary: | summary |