Clearance Summary
EARSCOPE received FDA 510(k) clearance under submission number K800365, sponsored by Nash & Assoc.. 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 1980-03-10.
- Submission: K800365
- Applicant / Sponsor: Nash & Assoc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4770
- Decision date: 1980-03-10
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.