Clearance Summary
TCD OR TCD NEUROPATHY STAR received FDA 510(k) clearance under submission number K944234, sponsored by Jcm Management & Planning 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 1995-03-08.
- Submission: K944234
- Applicant / Sponsor: Jcm Management & Planning Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1200
- Decision date: 1995-03-08
Classification & Regulation
This clearance is catalogued under FDA product code GWI and 21 CFR 882.1200, within the Neurology review panel as a Class I device.