Clearance Summary
MT10P, MT60-PP, MT60-AGC0, AND MT60 received FDA 510(k) clearance under submission number K962847, sponsored by Micro-Tech Hearing Instruments. 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 1996-08-09.
- Submission: K962847
- Applicant / Sponsor: Micro-Tech Hearing Instruments
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1996-08-09
Classification & Regulation
This clearance is catalogued under FDA product code ESD and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.