The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Fetasonde Fetal Heart Rate Variability.
| Device ID | K791039 |
| 510k Number | K791039 |
| Device Name: | FETASONDE FETAL HEART RATE VARIABILITY |
| Classification | System, Monitoring, Perinatal |
| Applicant | ROCHE MEDICAL ELECTRONICS, 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 | 1979-06-05 |
| Decision Date | 1979-09-04 |