Clearance Summary
TYTRON C-3000 received FDA 510(k) clearance under submission number K974208, sponsored by Titronics Research & Development Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1998-02-03.
- Submission: K974208
- Applicant / Sponsor: Titronics Research & Development Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1570
- Decision date: 1998-02-03
Classification & Regulation
This clearance is catalogued under FDA product code HCS and 21 CFR 882.1570, within the Neurology review panel as a Class II device.