Clearance Summary
NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 received FDA 510(k) clearance under submission number K905594, sponsored by Nihon Kohden America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1991-06-28.
- Submission: K905594
- Applicant / Sponsor: Nihon Kohden America, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1845
- Decision date: 1991-06-28
Classification & Regulation
This clearance is catalogued under FDA product code GWK and 21 CFR 882.1845, within the Neurology review panel as a Class II device.