Clearance Summary
MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM received FDA 510(k) clearance under submission number K891383, sponsored by Oxford Medilog, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1989-06-01.
- Submission: K891383
- Applicant / Sponsor: Oxford Medilog, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1989-06-01
Classification & Regulation
This clearance is catalogued under FDA product code OLZ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.