Clearance Summary
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 received FDA 510(k) clearance under submission number K990375, sponsored by Medtronic Functional Diagnostics A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1999-03-09.
- Submission: K990375
- Applicant / Sponsor: Medtronic Functional Diagnostics A/S
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1385
- Decision date: 1999-03-09
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.