Clearance Summary
NURITE II received FDA 510(k) clearance under submission number K780828, sponsored by Bio-Medical Systems Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1978-05-31.
- Submission: K780828
- Applicant / Sponsor: Bio-Medical Systems Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1978-05-31
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.