The following data is part of a premarket notification filed by Farus, Llc with the FDA for F1 Mothership Wireless Transducers For Fetal Ultrasonic And Tocodynamometer Monitoring.
| Device ID | K171865 |
| 510k Number | K171865 |
| Device Name: | F1 Mothership Wireless Transducers For Fetal Ultrasonic And Tocodynamometer Monitoring |
| Classification | System, Monitoring, Perinatal |
| Applicant | Farus, LLC 1240 Keystone Way Vista, CA 92081 |
| Contact | Rahul Singh |
| Correspondent | Rahul Singh Farus, LLC 1240 Keystone Way Vista, CA 92081 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-22 |
| Decision Date | 2017-08-24 |
| Summary: | summary |