Clearance Summary
RHINO-LARYNX STROBOSCOPE TYPE 4914 received FDA 510(k) clearance under submission number K842090, sponsored by Bruel & Kjaer Industri A/S. 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 1984-07-18.
- Submission: K842090
- Applicant / Sponsor: Bruel & Kjaer Industri A/S
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4750
- Decision date: 1984-07-18
Classification & Regulation
This clearance is catalogued under FDA product code EQL and 21 CFR 874.4750, within the Ear, Nose, Throat review panel as a Class I device.