Clearance Summary
TWIN NEUROTRAC-III received FDA 510(k) clearance under submission number K081551, sponsored by Astro-Med, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2008-12-24.
- Submission: K081551
- Applicant / Sponsor: Astro-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2008-12-24
Classification & Regulation
This clearance is catalogued under FDA product code OMA and 21 CFR 882.1400, within the Neurology review panel as a Class II device.