Elekon Industries U.S.A., Inc.
Country not established
- Devices
- 6
What Elekon Industries U.S.A., Inc. makes
Elekon Industries U.S.A., Inc. makes reusable and disposable SpO2 sensors, including finger clip sensors, ear sensors, and adhesive and non-adhesive variants, with specific models compatible with Nellcor, BCI, and Datex systems.
The company's devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Reusable Finger Clip SPO2 Sensors Ref K042704
Regimes: 510(k) Registry: 510(k)Disposable Non-Adhesive SPO2 Sensors Ref K042705
Regimes: 510(k) Registry: 510(k)Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible), (Datex-Compatible) Ref K041644
Regimes: 510(k) Registry: 510(k)Flexi-Stat SP02 Ear Sensor Ref K042675
Regimes: 510(k) Registry: 510(k)Flexi-Stat Disposable Adhesive SPO2 Sensors Ref K041522
Regimes: 510(k) Registry: 510(k)Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible), (Bci-Compatible), (Datex-Compatible) Ref K041647
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Elekon Industries U.S.A., Inc. have in the registry?
The registry currently lists 6 devices for Elekon Industries U.S.A., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elekon Industries U.S.A., Inc.'s devices?
Among its 6 most recently registered devices, Elekon Industries U.S.A., Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Elekon Industries U.S.A., Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Elekon Industries U.S.A., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elekon Industries U.S.A., Inc. in the registry?
The most recently registered devices listed for Elekon Industries U.S.A., Inc. include REUSABLE FINGER CLIP SPO2 SENSORS, DISPOSABLE NON-ADHESIVE SPO2 SENSORS, FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) and FLEXI-STAT SP02 EAR SENSOR.