Clearance Summary
REM440 received FDA 510(k) clearance under submission number K050496, sponsored by Interacoustics A/S, Assens. 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 2005-04-29.
- Submission: K050496
- Applicant / Sponsor: Interacoustics A/S, Assens
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3310
- Decision date: 2005-04-29
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.