Clearance Summary
BRACKMANN EMG MONITORING SYSTEM received FDA 510(k) clearance under submission number K895838, sponsored by Wr Medical Electronics Co.. 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 1990-03-27.
- Submission: K895838
- Applicant / Sponsor: Wr Medical Electronics Co.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 1990-03-27
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.