Asustek Computer, Inc.
TaiwanFDA applicant, unverified
- Devices
- 1
What Asustek Computer, Inc. makes
Asustek Computer, Inc. manufactures ultrasound imaging systems, including the ASUS LU800 series, designed for diagnostic medical imaging.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
ASUS Ultrasound Imaging System (LU800 series) Ref K250791
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Asustek Computer, Inc. have in the registry?
The registry currently lists 1 device for Asustek Computer, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Asustek Computer, Inc.'s devices?
Among its 1 most recently registered device, Asustek Computer, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Asustek Computer, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Asustek Computer, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Asustek Computer, Inc. in the registry?
The most recently registered devices listed for Asustek Computer, Inc. include ASUS Ultrasound Imaging System (LU800 series).