Clearance Summary
MINIOX 3000 OXYGEN MONITOR received FDA 510(k) clearance under submission number K961644, sponsored by Minesafety Appliances Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1996-07-25.
- Submission: K961644
- Applicant / Sponsor: Minesafety Appliances Co.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 1996-07-25
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.