The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Corometrics Fetal Movement Detection Kit.
| Device ID | K955559 |
| 510k Number | K955559 |
| Device Name: | COROMETRICS FETAL MOVEMENT DETECTION KIT |
| Classification | System, Monitoring, Perinatal |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Maria Vitug Fouts |
| Correspondent | Maria Vitug Fouts 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 | 1995-12-06 |
| Decision Date | 1996-03-05 |
| Summary: | summary |