South53, LLC
Country not established
- Devices
- 1
What South53, LLC makes
South53, LLC manufactures the Primero Safe Access System, a medical device designed for secure and controlled access to patient care areas, reducing contamination risks in healthcare environments.
The Primero Safe Access System 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
Primero Safe Access System Ref K252441
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does South53, LLC have in the registry?
The registry currently lists 1 device for South53, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list South53, LLC's devices?
Among its 1 most recently registered device, South53, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do South53, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for South53, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from South53, LLC in the registry?
The most recently registered devices listed for South53, LLC include Primero Safe Access System.