Clearance Summary
MOLIFT received FDA 510(k) clearance under submission number K851844, sponsored by Madshus 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 1985-05-17.
- Submission: K851844
- Applicant / Sponsor: Madshus A/S
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5510
- Decision date: 1985-05-17
Classification & Regulation
This clearance is catalogued under FDA product code FSA and 21 CFR 880.5510, within the General Hospital review panel as a Class I device.