Biolight International AB
Country not established
- Devices
- 1
What Biolight International AB makes
Biolight International AB manufactures the BIOLIGHT PCD, a portable cardiac defibrillator designed for emergency use in out-of-hospital settings. The device is intended for delivering electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest.
The BIOLIGHT PCD is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Biolight Pcd Ref K011355
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biolight International AB have in the registry?
The registry currently lists 1 device for Biolight International AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biolight International AB's devices?
Among its 1 most recently registered device, Biolight International AB has devices listed in FDA 510(k) (1 device).
What risk classes do Biolight International AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Biolight International AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biolight International AB in the registry?
The most recently registered devices listed for Biolight International AB include BIOLIGHT PCD.