Clearance Summary
GSI 2000 MIDDLE EAR ANALYZER received FDA 510(k) clearance under submission number K000097, sponsored by Grason-Stadler, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2000-04-12.
- Submission: K000097
- Applicant / Sponsor: Grason-Stadler, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1090
- Decision date: 2000-04-12
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.