The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To Corometrics Model 120is Maternal/fetal Monitoring System..
| Device ID | K012718 |
| 510k Number | K012718 |
| Device Name: | MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. |
| Classification | System, Monitoring, Perinatal |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Joelle Neider |
| Correspondent | Joelle Neider 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 | 2001-08-15 |
| Decision Date | 2001-11-13 |
| Summary: | summary |