meddevicedb.com FDA Device Reference

Tristel Duo ULT

DEN220041 Class II Direct
Decision Date
2023-06-02
Sponsor / Applicant
Tristel Solutions Limited

Technical Specification

510(k) Submission ID DEN220041
Product Code QWS
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.6886
Decision Date 2023-06-02
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

Tristel Duo ULT received FDA 510(k) clearance under submission number DEN220041, sponsored by Tristel Solutions Limited. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-06-02.

Classification & Regulation

This clearance is catalogued under FDA product code QWS and 21 CFR 880.6886, within the General Hospital review panel as a Class II device.