Clearance Summary
OXYGUARD received FDA 510(k) clearance under submission number K914978, sponsored by Stantex Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1992-01-10.
- Submission: K914978
- Applicant / Sponsor: Stantex Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 1992-01-10
Classification & Regulation
This clearance is catalogued under FDA product code MNK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.