Clearance Summary
M-XX OXYGEN SENSORS received FDA 510(k) clearance under submission number K002384, sponsored by International Business Strategies. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2000-12-15.
- Submission: K002384
- Applicant / Sponsor: International Business Strategies
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 2000-12-15
Classification & Regulation
This clearance is catalogued under FDA product code CCL and 21 CFR 868.1720, within the Anesthesiology review panel as a Class II device.