Clearance Summary
HYGROTHERM received FDA 510(k) clearance under submission number K800443, 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 1980-03-10.
- Submission: K800443
- Applicant / Sponsor: Jedmed Instrument Co.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.1800
- Decision date: 1980-03-10
Classification & Regulation
This clearance is catalogued under FDA product code ETP and 21 CFR 874.1800, within the Ear, Nose, Throat review panel as a Class I device.