Ino Therapeutics/Ikaria
Country not established
- Devices
- 2
What Ino Therapeutics/Ikaria makes
Ino Therapeutics/Ikaria manufactures inhaled nitric oxide delivery systems, including the INOmax DSIR Plus MRI and the INOMAX DSIR, designed for therapeutic administration in clinical settings. These devices are intended for controlled delivery of inhaled nitric oxide to support respiratory and cardiovascular functions in patients.
The company’s portfolio is classified under FDA Class II devices and is regulated through 510(k) clearance in the United States. The devices are listed in the FDA’s 510(k) registry, reflecting their authorised status for commercial distribution.
Catalogue
INOmax DSIR Plus MRI Ref K143213
Regimes: 510(k) Registry: 510(k)Inomax Dsir (Delivery System) Ref K131686
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ino Therapeutics/Ikaria have in the registry?
The registry currently lists 2 devices for Ino Therapeutics/Ikaria. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ino Therapeutics/Ikaria's devices?
Among its 2 most recently registered devices, Ino Therapeutics/Ikaria has devices listed in FDA 510(k) (2 devices).
What risk classes do Ino Therapeutics/Ikaria's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ino Therapeutics/Ikaria's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ino Therapeutics/Ikaria in the registry?
The most recently registered devices listed for Ino Therapeutics/Ikaria include INOmax DSIR Plus MRI and INOMAX DSIR (DELIVERY SYSTEM).