Clearance Summary
AIO HD OTOSCOPE received FDA 510(k) clearance under submission number K123821, sponsored by Blue Focus. 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 2013-05-17.
- Submission: K123821
- Applicant / Sponsor: Blue Focus
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4770
- Decision date: 2013-05-17
Classification & Regulation
This clearance is catalogued under FDA product code ERA and 21 CFR 874.4770, within the Ear, Nose, Throat review panel as a Class I device.