Clearance Summary
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 received FDA 510(k) clearance under submission number K002992, sponsored by Medtronic Functional Diagnostics 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 2001-08-15.
- Submission: K002992
- Applicant / Sponsor: Medtronic Functional Diagnostics A/S
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1385
- Decision date: 2001-08-15
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.