Children'S Hospital & Medical Center
Country not established
- Devices
- 1
What Children'S Hospital & Medical Center makes
The manufacturer produces the Clarren Helmet, a medical device designed for pediatric patients requiring non-invasive ventilation support, particularly for conditions such as obstructive sleep apnea or respiratory insufficiency.
The device falls under FDA Class II regulation and is listed via 510(k) clearance. The company is based in the United States.
Catalogue
Clarren Helmet Ref K003035
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Children'S Hospital & Medical Center have in the registry?
The registry currently lists 1 device for Children'S Hospital & Medical Center. Devices recorded under merged duplicate company entries are counted once.
Which registries list Children'S Hospital & Medical Center's devices?
Among its 1 most recently registered device, Children'S Hospital & Medical Center has devices listed in FDA 510(k) (1 device).
What risk classes do Children'S Hospital & Medical Center's devices fall under?
Among its 1 most recently registered device, the classes recorded for Children'S Hospital & Medical Center's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Children'S Hospital & Medical Center in the registry?
The most recently registered devices listed for Children'S Hospital & Medical Center include CLARREN HELMET.