Clearance Summary
iCOquit® Smokerlyzer® received FDA 510(k) clearance under submission number K211918, sponsored by Bedfont Scientific, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2021-12-21.
- Submission: K211918
- Applicant / Sponsor: Bedfont Scientific, Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1430
- Decision date: 2021-12-21
Classification & Regulation
This clearance is catalogued under FDA product code CCJ and 21 CFR 868.1430, within the Anesthesiology review panel as a Class II device.