Clearance Summary
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP received FDA 510(k) clearance under submission number K112634, sponsored by Inotec Amd , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2012-07-03.
- Submission: K112634
- Applicant / Sponsor: Inotec Amd , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5650
- Decision date: 2012-07-03
Classification & Regulation
This clearance is catalogued under FDA product code KPJ and 21 CFR 878.5650, within the General, Plastic Surgery review panel as a Class II device.