The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Model 2120is Series Maternal/fetal Monitor.
| Device ID | K021135 |
| 510k Number | K021135 |
| Device Name: | MODEL 2120IS SERIES MATERNAL/FETAL MONITOR |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-09 |
| Decision Date | 2002-05-09 |
| Summary: | summary |