Shenzhen Envisen Industry Co. Limited
Country not established
- Devices
- 1
What Shenzhen Envisen Industry Co. Limited makes
Shenzhen Envisen Industry Co. Limited manufactures pulse oximetry sensors designed for compatibility with multiple medical platforms, including Nellcor, BCI, Nonin, CSI, HP/Philips, and Datex-Ohmeda systems. Their portfolio includes both disposable and reusable SPO₂ sensors, which measure oxygen saturation levels in patients.
These devices fall under FDA Class II regulation and are listed via 510(k) clearance in the United States. The company is based in the US.
Catalogue
Envisen Nellcor, Bci, Nonin, Csi, Hp/Philips, Datex-Ohmeda Compatible Disposable And Reusable SPO2 Sensors Ref K103584
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 529112578
Frequently asked questions
How many devices does Shenzhen Envisen Industry Co. Limited have in the registry?
The registry currently lists 1 device for Shenzhen Envisen Industry Co. Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Envisen Industry Co. Limited's devices?
Among its 1 most recently registered device, Shenzhen Envisen Industry Co. Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Shenzhen Envisen Industry Co. Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Shenzhen Envisen Industry Co. Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Envisen Industry Co. Limited in the registry?
The most recently registered devices listed for Shenzhen Envisen Industry Co. Limited include ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS.