Clearance Summary
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE received FDA 510(k) clearance under submission number K093825, sponsored by Ambu 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 2010-01-13.
- Submission: K093825
- Applicant / Sponsor: Ambu A/S
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1385
- Decision date: 2010-01-13
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.