The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Corometrics Model 171 And 172 Fetal Monitor.
| Device ID | K991905 |
| 510k Number | K991905 |
| Device Name: | COROMETRICS MODEL 171 AND 172 FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 61 BARNES PARK RD. NORTH Wallingford, CT 06492 -0333 |
| Contact | Richard Cehovsky |
| Correspondent | Richard Cehovsky GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 61 BARNES PARK RD. NORTH Wallingford, CT 06492 -0333 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-04 |
| Decision Date | 1999-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103848 | K991905 | 000 |
| 00840682103831 | K991905 | 000 |