Sumitomo Electric Industries, Inc.
Country not established
- Devices
- 2
What Sumitomo Electric Industries, Inc. makes
Sumitomo Electric Industries, Inc. manufactures pulse oximetry devices, including the PO-510 TCPO₂ Monitor for transcutaneous carbon dioxide monitoring and the PO-200 Blood Oxygen Monitor for continuous noninvasive blood oxygen saturation measurement.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Po-510 TCPO2 Monitor Ref K852959
Regimes: 510(k) Registry: 510(k)Po-200 Blood Oxygen Monitor Ref K811836
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sumitomo Electric Industries, Inc. have in the registry?
The registry currently lists 2 devices for Sumitomo Electric Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sumitomo Electric Industries, Inc.'s devices?
Among its 2 most recently registered devices, Sumitomo Electric Industries, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sumitomo Electric Industries, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sumitomo Electric Industries, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sumitomo Electric Industries, Inc. in the registry?
The most recently registered devices listed for Sumitomo Electric Industries, Inc. include PO-510 TCPO2 MONITOR and PO-200 BLOOD OXYGEN MONITOR.