Clearance Summary
ISOTRON III, ISOTRON IV received FDA 510(k) clearance under submission number K955387, sponsored by Excel Tech. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1996-03-22.
- Submission: K955387
- Applicant / Sponsor: Excel Tech. , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1996-03-22
Classification & Regulation
This clearance is catalogued under FDA product code LIH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.