Clearance Summary
FUJITENS III received FDA 510(k) clearance under submission number K893874, sponsored by Altoona Medical Supply. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1989-12-22.
- Submission: K893874
- Applicant / Sponsor: Altoona Medical Supply
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4275
- Decision date: 1989-12-22
Classification & Regulation
This clearance is catalogued under FDA product code GZQ and 21 CFR 882.4275, within the Neurology review panel as a Class II device.