The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Corometrics Mdl 330 Fetal/maternal Telemetry Syst.
| Device ID | K910260 |
| 510k Number | K910260 |
| Device Name: | COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST |
| 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 | 1991-01-22 |
| Decision Date | 1991-03-15 |