Clearance Summary
SafeAir combi (SFR-combi-US) received FDA 510(k) clearance under submission number K223932, sponsored by Lina Medical Aps. 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 2023-04-26.
- Submission: K223932
- Applicant / Sponsor: Lina Medical Aps
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2023-04-26
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.