Clearance Summary
MEDI-DX 7000 received FDA 510(k) clearance under submission number K964622, sponsored by Neuro-Diagnostic Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-12-01.
- Submission: K964622
- Applicant / Sponsor: Neuro-Diagnostic Assoc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1200
- Decision date: 1997-12-01
Classification & Regulation
This clearance is catalogued under FDA product code LLN and 21 CFR 882.1200, within the Neurology review panel as a Class I device.