The following data is part of a premarket notification filed by Philips Medizin Systeme Boblingen Gmbh with the FDA for Philips Avalon Fetal / Maternal Monitors Fm20, Fm30, Fm40 And Fm50.
| Device ID | K140535 |
| 510k Number | K140535 |
| Device Name: | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 |
| Classification | System, Monitoring, Perinatal |
| Applicant | PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen, DE D-71034 |
| Contact | Michael Asmalsky |
| Correspondent | Michael Asmalsky PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen, DE D-71034 |
| Product Code | HGM |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DRQ |
| Subsequent Product Code | DRS |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSF |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | DXQ |
| Subsequent Product Code | FLL |
| Subsequent Product Code | HFM |
| Subsequent Product Code | HFN |
| Subsequent Product Code | HGL |
| Subsequent Product Code | JOM |
| Subsequent Product Code | MSX |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838034259 | K140535 | 000 |
| 00884838000407 | K140535 | 000 |
| 00884838000414 | K140535 | 000 |
| 00884838000421 | K140535 | 000 |
| 00884838000438 | K140535 | 000 |
| 00884838001404 | K140535 | 000 |
| 00884838001411 | K140535 | 000 |
| 00884838002715 | K140535 | 000 |
| 00884838002722 | K140535 | 000 |
| 00884838009950 | K140535 | 000 |
| 00884838009974 | K140535 | 000 |
| 00884838010338 | K140535 | 000 |
| 00884838012141 | K140535 | 000 |
| 00884838021471 | K140535 | 000 |
| 00884838021488 | K140535 | 000 |
| 00884838034228 | K140535 | 000 |
| 00884838034235 | K140535 | 000 |
| 00884838034242 | K140535 | 000 |
| 20884838059324 | K140535 | 000 |