Clearance Summary
NeuroAmp II, NeuroAmp II.5s received FDA 510(k) clearance under submission number K193159, sponsored by Corscience GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-12-30.
- Submission: K193159
- Applicant / Sponsor: Corscience GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2020-12-30
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.