Fhk
Country not established
- Devices
- 1
What Fhk makes
Fhk manufactures hemodialysis systems designed for the treatment of acute and chronic kidney failure, providing controlled filtration of blood through a semipermeable membrane to remove waste and excess fluids.
The company’s hemodialysis systems are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The portfolio is regulated in the United States.
Catalogue
Hemodialysis System Ref K813432
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fhk have in the registry?
The registry currently lists 1 device for Fhk. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fhk's devices?
Among its 1 most recently registered device, Fhk has devices listed in FDA 510(k) (1 device).
What risk classes do Fhk's devices fall under?
Among its 1 most recently registered device, the classes recorded for Fhk's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fhk in the registry?
The most recently registered devices listed for Fhk include HEMODIALYSIS SYSTEM.