The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Model 250 Series Maternal/fetal Monitor.
| Device ID | K050583 |
| 510k Number | K050583 |
| Device Name: | MODEL 250 SERIES MATERNAL/FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORPORATE BLVD. Tampa, FL 33614 |
| Contact | Melissa Robinson |
| Correspondent | Melissa Robinson GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORPORATE BLVD. Tampa, FL 33614 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-07 |
| Decision Date | 2005-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682116367 | K050583 | 000 |
| 00840682103046 | K050583 | 000 |