Clearance Summary
ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM received FDA 510(k) clearance under submission number K901503, sponsored by Stanton Magnetics, 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 1990-06-28.
- Submission: K901503
- Applicant / Sponsor: Stanton Magnetics, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3375
- Decision date: 1990-06-28
Classification & Regulation
This clearance is catalogued under FDA product code ESE and 21 CFR 874.3375, within the Ear, Nose, Throat review panel as a Class I device.