Clearance Summary
AUDIOTECH MODEL SPI received FDA 510(k) clearance under submission number K950963, sponsored by Muskogee Regional Hearing Aid Lab. 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 1995-05-25.
- Submission: K950963
- Applicant / Sponsor: Muskogee Regional Hearing Aid Lab
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1995-05-25
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.