meddevicedb.com FDA Device Reference

Hemolung Respiratory Assist System

DEN210006 Class II Direct
Decision Date
2021-11-13
Sponsor / Applicant
Alung Technologies, Inc.

Technical Specification

510(k) Submission ID DEN210006
Product Code QOH
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.4150
Decision Date 2021-11-13
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

Hemolung Respiratory Assist System received FDA 510(k) clearance under submission number DEN210006, sponsored by Alung Technologies, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-11-13.

Classification & Regulation

This clearance is catalogued under FDA product code QOH and 21 CFR 870.4150, within the Cardiovascular review panel as a Class II device.