Clearance Summary
ASC-954 INTEGRATOR AMPLIFIER received FDA 510(k) clearance under submission number K896164, 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 1990-01-22.
- Submission: K896164
- Applicant / Sponsor: Astro-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1845
- Decision date: 1990-01-22
Classification & Regulation
This clearance is catalogued under FDA product code GWK and 21 CFR 882.1845, within the Neurology review panel as a Class II device.