Clearance Summary
LISS CRANIAL STIMULATOR MODEL SBL201-M received FDA 510(k) clearance under submission number K894515, sponsored by Medical Consultants Intl. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1990-05-03.
- Submission: K894515
- Applicant / Sponsor: Medical Consultants Intl. , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5800
- Decision date: 1990-05-03
Classification & Regulation
This clearance is catalogued under FDA product code QJQ and 21 CFR 882.5800, within the Neurology review panel as a Class II device.