Clearance Summary
GSI SA60 DPOAE SYSTEM received FDA 510(k) clearance under submission number K970324, sponsored by 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 1997-06-06.
- Submission: K970324
- Applicant / Sponsor: Grason-Stadler, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3310
- Decision date: 1997-06-06
Classification & Regulation
This clearance is catalogued under FDA product code ETW and 21 CFR 874.3310, within the Ear, Nose, Throat review panel as a Class II device.