Clearance Summary
MODEL 02 OXYGEN ANALYZER received FDA 510(k) clearance under submission number K971084, sponsored by Oxigraf, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1998-07-21.
- Submission: K971084
- Applicant / Sponsor: Oxigraf, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 1998-07-21
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.