Clearance Summary
GSI 38 AUTO TYMP received FDA 510(k) clearance under submission number K925585, sponsored by Lucas Grason-Stadler, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1993-02-02.
- Submission: K925585
- Applicant / Sponsor: Lucas Grason-Stadler, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1090
- Decision date: 1993-02-02
Classification & Regulation
This clearance is catalogued under FDA product code ETY and 21 CFR 874.1090, within the Ear, Nose, Throat review panel as a Class II device.