Clearance Summary
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES received FDA 510(k) clearance under submission number K973529, sponsored by Medicotest A/S. 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 1997-11-20.
- Submission: K973529
- Applicant / Sponsor: Medicotest A/S
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1385
- Decision date: 1997-11-20
Classification & Regulation
This clearance is catalogued under FDA product code IKT and 21 CFR 890.1385, within the Physical Medicine review panel as a Class II device.