The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Model 250cx Series Maternal/fetal Monitor.
| Device ID | K072976 |
| 510k Number | K072976 |
| Device Name: | MODEL 250CX SERIES MATERNAL/FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | GE HEALTHCARE 8880 GORMAN RD Laurel, MD 20723 |
| Contact | Agata Smieja |
| Correspondent | Agata Smieja GE HEALTHCARE 8880 GORMAN RD Laurel, MD 20723 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-25 |
| Decision Date | 2007-12-20 |
| Summary: | summary |