Niko Medical Products
Country not established
- Devices
- 1
What Niko Medical Products makes
Niko Medical Products manufactures neonatal ECG electrodes designed for use in monitoring heart activity in newborns. These adhesive electrodes are intended for single-use applications in clinical settings, providing reliable electrical contact for electrocardiogram (ECG) recordings.
The company’s ECG electrodes are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The products are listed in the FDA’s 510(k) database. Niko Medical Products is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Niko Medical Products have in the registry?
The registry currently lists 1 device for Niko Medical Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Niko Medical Products's devices?
Among its 1 most recently registered device, Niko Medical Products has devices listed in FDA 510(k) (1 device).
What risk classes do Niko Medical Products's devices fall under?
Among its 1 most recently registered device, the classes recorded for Niko Medical Products's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Niko Medical Products in the registry?
The most recently registered devices listed for Niko Medical Products include SENSI-PREMA NEONATAL ECG ELECTRODES, 40612, 40614, 40626, 40550, 40554, 40555, 440556, 40610, 40613, 40625, 40801.