Clearance Summary
ABR-2000 received FDA 510(k) clearance under submission number K020360, sponsored by Meridian Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-08-29.
- Submission: K020360
- Applicant / Sponsor: Meridian Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1540
- Decision date: 2002-08-29
Classification & Regulation
This clearance is catalogued under FDA product code GZO and 21 CFR 882.1540, within the Neurology review panel as a Class II device.