Clearance Summary
°M Warmer System received FDA 510(k) clearance under submission number K232107, sponsored by Mequ A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-05-31.
- Submission: K232107
- Applicant / Sponsor: Mequ A/S
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2024-05-31
Classification & Regulation
This clearance is catalogued under FDA product code LGZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.