The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Corometrics Model 173 Fetal Monitor.
| Device ID | K993751 |
| 510k Number | K993751 |
| Device Name: | COROMETRICS MODEL 173 FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Richard Cehovsky |
| Correspondent | Richard Cehovsky 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 | 1999-11-05 |
| Decision Date | 2000-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103879 | K993751 | 000 |