Clearance Summary
MODEL BION 1/TYPE 1084T CAR IONIZER received FDA 510(k) clearance under submission number K851094, sponsored by Medicor USA , 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 1985-06-19.
- Submission: K851094
- Applicant / Sponsor: Medicor USA , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5045
- Decision date: 1985-06-19
Classification & Regulation
This clearance is catalogued under FDA product code FRF and 21 CFR 880.5045, within the General Hospital review panel as a Class II device.