The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Model 118 Fetal/maternal Monitor.
| Device ID | K934959 |
| 510k Number | K934959 |
| Device Name: | MODEL 118 FETAL/MATERNAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Brian R Barry |
| Correspondent | Brian R Barry GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-15 |
| Decision Date | 1994-08-15 |