Clearance Summary
OSSDSIGN Cranial PSI received FDA 510(k) clearance under submission number K212414, sponsored by Ossdsign AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-10-01.
- Submission: K212414
- Applicant / Sponsor: Ossdsign AB
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5330
- Decision date: 2021-10-01
Classification & Regulation
This clearance is catalogued under FDA product code PJN and 21 CFR 882.5330, within the Neurology review panel as a Class II device.