The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Corometrics 120 Series Maternal/fetal Monitor.
| Device ID | K991739 |
| 510k Number | K991739 |
| Device Name: | COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 200 HARRY SOUTH TRUMAN PKWY. SUITE 220 Annapolis, MD 21401 |
| Contact | Maria Vitug Fouts |
| Correspondent | Maria Vitug Fouts GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 200 HARRY SOUTH TRUMAN PKWY. SUITE 220 Annapolis, MD 21401 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-21 |
| Decision Date | 1999-08-19 |
| Summary: | summary |