Clearance Summary
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) received FDA 510(k) clearance under submission number K000812, sponsored by Neurosoft, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2000-05-17.
- Submission: K000812
- Applicant / Sponsor: Neurosoft, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 2000-05-17
Classification & Regulation
This clearance is catalogued under FDA product code IKN and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.