Clearance Summary
NIHON KOHDEN AE-918P NEURO UNIT received FDA 510(k) clearance under submission number K130238, sponsored by Nihon Kohden Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-03-04.
- Submission: K130238
- Applicant / Sponsor: Nihon Kohden Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2015-03-04
Classification & Regulation
This clearance is catalogued under FDA product code OMA and 21 CFR 882.1400, within the Neurology review panel as a Class II device.