Clearance Summary
GSI TympStar Pro Middle Ear Analyzer received FDA 510(k) clearance under submission number K151509, sponsored by Diagnostic Group, Dba Grason-Stadler. 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 2015-06-25.
- Submission: K151509
- Applicant / Sponsor: Diagnostic Group, Dba Grason-Stadler
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1090
- Decision date: 2015-06-25
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.