The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Philips Avalon Fetal Monitors Fm20, Fm30, Fm40, And Fm50.
| Device ID | K092028 |
| 510k Number | K092028 |
| Device Name: | PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 |
| Classification | System, Monitoring, Perinatal |
| Applicant | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen, DE D-71034 |
| Contact | Michael Asmalsky |
| Correspondent | Michael Asmalsky PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen, DE D-71034 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2010-02-17 |
| Summary: | summary |