Clearance Summary
EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET received FDA 510(k) clearance under submission number K853856, sponsored by Aequitron Medical, Inc.. 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 1986-03-12.
- Submission: K853856
- Applicant / Sponsor: Aequitron Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2720
- Decision date: 1986-03-12
Classification & Regulation
This clearance is catalogued under FDA product code HFM and 21 CFR 884.2720, within the Obstetrics/Gynecology review panel as a Class II device.