Clearance Summary
AURAL-CAM, VIDEO EAR, VID RX received FDA 510(k) clearance under submission number K941659, sponsored by Gracefully Yours, 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 1994-04-26.
- Submission: K941659
- Applicant / Sponsor: Gracefully Yours, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4770
- Decision date: 1994-04-26
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.