Clearance Summary
OZONE GENERATOR received FDA 510(k) clearance under submission number K043207, sponsored by Ge Infrastructure Water & Process Technologies. 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 2005-11-04.
- Submission: K043207
- Applicant / Sponsor: Ge Infrastructure Water & Process Technologies
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2005-11-04
Classification & Regulation
This clearance is catalogued under FDA product code NII and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.