Clearance Summary
RESOLVE OPEN BACK HALO RINGS received FDA 510(k) clearance under submission number K051918, sponsored by Jerome Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2005-08-17.
- Submission: K051918
- Applicant / Sponsor: Jerome Medical
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5960
- Decision date: 2005-08-17
Classification & Regulation
This clearance is catalogued under FDA product code HAX and 21 CFR 882.5960, within the Neurology review panel as a Class II device.