The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Fetasonde 5, #30, Central Nursing Stat.
| Device ID | K812863 |
| 510k Number | K812863 |
| Device Name: | FETASONDE 5, #30, CENTRAL NURSING STAT |
| Classification | System, Monitoring, Perinatal |
| Applicant | KONTRON INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-13 |
| Decision Date | 1981-11-06 |