Clearance Summary
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE received FDA 510(k) clearance under submission number K071185, sponsored by Ambu A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-05-30.
- Submission: K071185
- Applicant / Sponsor: Ambu A/S
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1350
- Decision date: 2007-05-30
Classification & Regulation
This clearance is catalogued under FDA product code GXZ and 21 CFR 882.1350, within the Neurology review panel as a Class II device.