FDA Product Code NOU: Continuous, Ventilator, Home Use
This Product Code Was Needed For The Home Use Indication. Cbk Is Not A Tracked Device And Nou Is A Tracked Device.
Leading manufacturers include Breas Medical AB.
FDA 510(k) Cleared Continuous, Ventilator, Home Use Devices (Product Code NOU)
About Product Code NOU - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code NOU since 2003, with 7 receiving FDA clearance (average review time: 332 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NOU have taken an average of 451 days to reach a decision - up from 313 days historically. Manufacturers should account for longer review timelines in current project planning.
NOU devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →