Clearance Summary
HEARIT received FDA 510(k) clearance under submission number K934805, sponsored by Je Liss & Co., 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 1994-02-07.
- Submission: K934805
- Applicant / Sponsor: Je Liss & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3320
- Decision date: 1994-02-07
Classification & Regulation
This clearance is catalogued under FDA product code LZI and 21 CFR 874.3320, within the Ear, Nose, Throat review panel as a Class II device.