Clearance Summary
ER36 Series OAE Test System received FDA 510(k) clearance under submission number K150491, sponsored by Etymotic Research, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2015-03-26.
- Submission: K150491
- Applicant / Sponsor: Etymotic Research, Inc.
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 2015-03-26
Classification & Regulation
This clearance is catalogued under FDA product code EWO and 21 CFR 874.1050, within the Ear, Nose, Throat review panel as a Class II device.