Clearance Summary
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY received FDA 510(k) clearance under submission number K954717, sponsored by Sodem Diffusion SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-01-22.
- Submission: K954717
- Applicant / Sponsor: Sodem Diffusion SA
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4370
- Decision date: 1997-01-22
Classification & Regulation
This clearance is catalogued under FDA product code HBB and 21 CFR 882.4370, within the Neurology review panel as a Class II device.