The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Fetal Monitoring System.
| Device ID | K780487 |
| 510k Number | K780487 |
| Device Name: | FETAL MONITORING SYSTEM |
| Classification | Recorder, Pressure, Intrauterine |
| Applicant | SONICAID, INC. VA |
| Product Code | HFO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-27 |
| Decision Date | 1978-05-09 |