Clearance Summary
DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123 received FDA 510(k) clearance under submission number K944314, sponsored by Bio-Logic Systems Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1996-01-03.
- Submission: K944314
- Applicant / Sponsor: Bio-Logic Systems Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1996-01-03
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.