Western Graphtec
Country not established
- Devices
- 1
What Western Graphtec makes
Western Graphtec manufactures the WR3500 and WR3600 series of medical recorders, designed for capturing and storing physiological data such as ECG signals.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
WR3500 And WR3600 Series Recorders Ref K894922
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Western Graphtec have in the registry?
The registry currently lists 1 device for Western Graphtec. Devices recorded under merged duplicate company entries are counted once.
Which registries list Western Graphtec's devices?
Among its 1 most recently registered device, Western Graphtec has devices listed in FDA 510(k) (1 device).
What risk classes do Western Graphtec's devices fall under?
Among its 1 most recently registered device, the classes recorded for Western Graphtec's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Western Graphtec in the registry?
The most recently registered devices listed for Western Graphtec include WR3500 AND WR3600 SERIES RECORDERS.