F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring— 510(k) K171865
Substantially EquivalentFarus, LLC
FDA 510(k) clearance K171865 for F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring, Substantially Equivalent on 2017-08-24. Applicant: Farus, LLC.
Clearance details
- Applicant
- Farus, LLC
- Product code
- Code HGM
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vista, CA, US
Adverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.