Clearance Summary
CRITERION II & IIA OXYGEN CONCENTRATORS received FDA 510(k) clearance under submission number K871603, sponsored by Timeter Instrument Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1987-08-13.
- Submission: K871603
- Applicant / Sponsor: Timeter Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1987-08-13
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.