Clearance Summary
THE SCREENER GSI 55 ABR SCREENER received FDA 510(k) clearance under submission number K870030, sponsored by Grason-Stadler, 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 1987-03-13.
- Submission: K870030
- Applicant / Sponsor: Grason-Stadler, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 1987-03-13
Classification & Regulation
This clearance is catalogued under FDA product code GWJ and 21 CFR 882.1900, within the Neurology review panel as a Class II device.