Clearance Summary
INHALATOR MODELS 8100, 10100 AND 10200 received FDA 510(k) clearance under submission number K862194, sponsored by U.O. Equipment 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 1986-07-28.
- Submission: K862194
- Applicant / Sponsor: U.O. Equipment Co.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1986-07-28
Classification & Regulation
This clearance is catalogued under FDA product code CAW and 21 CFR 868.5440, within the Anesthesiology review panel as a Class II device.