Clearance Summary
PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR) received FDA 510(k) clearance under submission number K921085, sponsored by Hear-Well Technologies, 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 1992-05-15.
- Submission: K921085
- Applicant / Sponsor: Hear-Well Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1992-05-15
Classification & Regulation
This clearance is catalogued under FDA product code EWO and 21 CFR 874.1050, within the Ear, Nose, Throat review panel as a Class II device.