Clearance Summary
Comfort Marker 2.0 received FDA 510(k) clearance under submission number K222112, sponsored by Medical Precision BV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-03-30.
- Submission: K222112
- Applicant / Sponsor: Medical Precision BV
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5785
- Decision date: 2023-03-30
Classification & Regulation
This clearance is catalogued under FDA product code QRN and 21 CFR 892.5785, within the Radiology review panel as a Class II device.