Clearance Summary
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM received FDA 510(k) clearance under submission number K963669, 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 1996-12-12.
- Submission: K963669
- Applicant / Sponsor: Astro-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1835
- Decision date: 1996-12-12
Classification & Regulation
This clearance is catalogued under FDA product code GWL and 21 CFR 882.1835, within the Neurology review panel as a Class II device.