Clearance Summary
T-M (TIME-MOTION) OPTION received FDA 510(k) clearance under submission number K761139, sponsored by G.D. Searle and Co.. 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 1976-12-16.
- Submission: K761139
- Applicant / Sponsor: G.D. Searle and Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1976-12-16
Classification & Regulation
This clearance is catalogued under FDA product code HGM and 21 CFR 884.2740, within the Obstetrics/Gynecology review panel as a Class II device.