Clearance Summary
SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM received FDA 510(k) clearance under submission number K853178, 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 1986-02-28.
- Submission: K853178
- Applicant / Sponsor: Oxford Medilog, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5235
- Decision date: 1986-02-28
Classification & Regulation
This clearance is catalogued under FDA product code HCB and 21 CFR 882.5235, within the Neurology review panel as a Class II device.