Clearance Summary
LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 received FDA 510(k) clearance under submission number K072688, sponsored by International Biophysics Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2008-01-11.
- Submission: K072688
- Applicant / Sponsor: International Biophysics Corp.
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2008-01-11
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.