The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Omf-7101 Fetal Monitor.
| Device ID | K860237 |
| 510k Number | K860237 |
| Device Name: | OMF-7101 FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Dennis Javens |
| Correspondent | Dennis Javens NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-23 |
| Decision Date | 1986-09-05 |