meddevicedb.com FDA Device Reference

Comfort Marker 2.0.

DEN200041 Class II Direct
Decision Date
2021-12-10
Sponsor / Applicant
Medical Precision BV

Technical Specification

510(k) Submission ID DEN200041
Product Code QRN
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.5785
Decision Date 2021-12-10
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Comfort Marker 2.0. received FDA 510(k) clearance under submission number DEN200041, sponsored by Medical Precision BV. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-12-10.

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.