Koratek Company, Ltd.
Country not established
- Devices
- 1
What Koratek Company, Ltd. makes
Koratek Company, Ltd. manufactures the AUSCO ES-3100, an electrocardiogram (ECG) system designed for cardiac monitoring and diagnostic purposes.
The AUSCO ES-3100 is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Ausco Es-3100 Ref K070550
510(k) 510(k)
Frequently asked questions
How many devices does Koratek Company, Ltd. have in the registry?
The registry currently lists 1 device for Koratek Company, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Koratek Company, Ltd.'s devices?
Among its 1 most recently registered device, Koratek Company, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Koratek Company, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Koratek Company, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Koratek Company, Ltd. in the registry?
The most recently registered devices listed for Koratek Company, Ltd. include AUSCO ES-3100.