Clearance Summary
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM received FDA 510(k) clearance under submission number K132039, sponsored by Jedmed Instrument Co.. 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 2014-02-21.
- Submission: K132039
- Applicant / Sponsor: Jedmed Instrument Co.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4760
- Decision date: 2014-02-21
Classification & Regulation
This clearance is catalogued under FDA product code EQN and 21 CFR 874.4760, within the Ear, Nose, Throat review panel as a Class II device.