Clearance Summary
ELIBRA SOFT-TISSUE FORCE SENSOR received FDA 510(k) clearance under submission number K132104, sponsored by Kamm & Associates. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2014-03-21.
- Submission: K132104
- Applicant / Sponsor: Kamm & Associates
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2014-03-21
Classification & Regulation
This clearance is catalogued under FDA product code ONN and 21 CFR 882.4560, within the Neurology review panel as a Class II device.