Perinatal Systems
Country not established
- Devices
- 1
What Perinatal Systems makes
Perinatal Systems manufactures the LOBOW, a device designed for neonatal respiratory support, specifically for oxygen delivery in infants.
The LOBOW is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Lobow Ref K905250
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Perinatal Systems have in the registry?
The registry currently lists 1 device for Perinatal Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Perinatal Systems's devices?
Among its 1 most recently registered device, Perinatal Systems has devices listed in FDA 510(k) (1 device).
What risk classes do Perinatal Systems's devices fall under?
Among its 1 most recently registered device, the classes recorded for Perinatal Systems's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Perinatal Systems in the registry?
The most recently registered devices listed for Perinatal Systems include LOBOW.