Clearance Summary
NERVE MONITOR ELECTRODES/STIMULATOR PROBES received FDA 510(k) clearance under submission number K945242, sponsored by Micromed Development Corp.. 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 1994-12-27.
- Submission: K945242
- Applicant / Sponsor: Micromed Development Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 1994-12-27
Classification & Regulation
This clearance is catalogued under FDA product code ETN and 21 CFR 874.1820, within the Ear, Nose, Throat review panel as a Class II device.