Clearance Summary
FORTEC MI-305 received FDA 510(k) clearance under submission number K851873, sponsored by Nam Tai , Ltd.. 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 1985-05-13.
- Submission: K851873
- Applicant / Sponsor: Nam Tai , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1985-05-13
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.