Clearance Summary
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE received FDA 510(k) clearance under submission number K932259, sponsored by Clarus Medical Systems, 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 1993-12-15.
- Submission: K932259
- Applicant / Sponsor: Clarus Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4770
- Decision date: 1993-12-15
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.