Clearance Summary
EVOKED RESPONSE STIMULATORS received FDA 510(k) clearance under submission number K803226, 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 1981-02-05.
- Submission: K803226
- Applicant / Sponsor: Bio-Logic Systems Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1845
- Decision date: 1981-02-05
Classification & Regulation
This clearance is catalogued under FDA product code GWK and 21 CFR 882.1845, within the Neurology review panel as a Class II device.