Clearance Summary
EDINBURGH MASKER received FDA 510(k) clearance under submission number K800445, sponsored by Foundation For Fluency, 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 1980-03-12.
- Submission: K800445
- Applicant / Sponsor: Foundation For Fluency, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5840
- Decision date: 1980-03-12
Classification & Regulation
This clearance is catalogued under FDA product code KTH and 21 CFR 874.5840, within the Ear, Nose, Throat review panel as a Class I device.