The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Philips Avalon Fetal Monitors Fm20 And Fm30.
| Device ID | K071800 |
| 510k Number | K071800 |
| Device Name: | PHILIPS AVALON FETAL MONITORS FM20 AND FM30 |
| Classification | System, Monitoring, Perinatal |
| Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, Baden-wuerttemberg, DE D 71034 |
| Contact | Michael Asmalsky |
| Correspondent | Michael Asmalsky PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, Baden-wuerttemberg, DE D 71034 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2007-09-27 |
| Summary: | summary |