Clearance Summary
TOCO LITE, MODEL TD-01 received FDA 510(k) clearance under submission number K013477, sponsored by Ventrex, 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 2002-01-17.
- Submission: K013477
- Applicant / Sponsor: Ventrex, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2720
- Decision date: 2002-01-17
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.