Clearance Summary
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER received FDA 510(k) clearance under submission number K854835, sponsored by Miracle-Ear/Dahlberg, 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 1986-03-04.
- Submission: K854835
- Applicant / Sponsor: Miracle-Ear/Dahlberg, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1986-03-04
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.