Clearance Summary
AIR-CUSHION TOCOTONOMETER received FDA 510(k) clearance under submission number K860933, sponsored by International Biomedics, 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 1986-07-09.
- Submission: K860933
- Applicant / Sponsor: International Biomedics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2720
- Decision date: 1986-07-09
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.