Clearance Summary
NEURO-AIDE received FDA 510(k) clearance under submission number K942926, sponsored by Burke Neutech, 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 1994-08-03.
- Submission: K942926
- Applicant / Sponsor: Burke Neutech, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1750
- Decision date: 1994-08-03
Classification & Regulation
This clearance is catalogued under FDA product code GWY and 21 CFR 882.1750, within the Neurology review panel as a Class I device.