Niagara Corp.
Country not established
- Devices
- 1
What Niagara Corp. makes
Niagara Corp. manufactures the RAOMER, a medical device designed for respiratory assistance in neonatal and pediatric patients, including those requiring non-invasive ventilation or high-flow oxygen therapy.
The RAOMER is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Raomer Ref K894112
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Niagara Corp. have in the registry?
The registry currently lists 1 device for Niagara Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Niagara Corp.'s devices?
Among its 1 most recently registered device, Niagara Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Niagara Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Niagara Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Niagara Corp. in the registry?
The most recently registered devices listed for Niagara Corp. include RAOMER.