Gl Ultrasound, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 3
What Gl Ultrasound, Ltd. makes
Gl Ultrasound, Ltd. manufactures diagnostic ultrasound equipment, including portable systems like the GL ULTRASOUND Z/SL 8300 and specialized probes such as the GL ULTRASOUND SECTOR 170. Their portfolio also includes standalone diagnostic ultrasound units, such as the GL590, designed for medical imaging applications.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance process. These devices are intended for use in the United States, where regulatory compliance is required for market authorization.
Catalogue
Gl Ultrasound Z/Sl 8300 Ref K843205
Regimes: 510(k) Registry: 510(k)GL590 Diagnostic Ultrasound Equipment Ref K854555
Regimes: 510(k) Registry: 510(k)Gl Ultrasound Sector 170 Ref K844393
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gl Ultrasound, Ltd. have in the registry?
The registry currently lists 3 devices for Gl Ultrasound, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gl Ultrasound, Ltd.'s devices?
Among its 3 most recently registered devices, Gl Ultrasound, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Gl Ultrasound, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Gl Ultrasound, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gl Ultrasound, Ltd. in the registry?
The most recently registered devices listed for Gl Ultrasound, Ltd. include GL ULTRASOUND Z/SL 8300, GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT and GL ULTRASOUND SECTOR 170.