Clearance Summary
FMS MODEL 110 received FDA 510(k) clearance under submission number K863736, sponsored by Flir Medical Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1986-12-29.
- Submission: K863736
- Applicant / Sponsor: Flir Medical Systems
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.2980
- Decision date: 1986-12-29
Classification & Regulation
This clearance is catalogued under FDA product code IYM and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class III device.