Clearance Summary
EEG NEUROAMP, MODEL CS10137 received FDA 510(k) clearance under submission number K073557, 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 2008-02-28.
- Submission: K073557
- Applicant / Sponsor: Corscience GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 2008-02-28
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.