Acuitas Medical, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Acuitas Medical, Ltd. makes
Acuitas Medical, Ltd. manufactures the fineSA, a device designed for fine structure analysis, likely used in microscopic or histological evaluations to assess tissue or cellular morphology.
The company’s portfolio is regulated under FDA Class II devices, with the fineSA authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Fine Structure Analysis(fineSA) Ref K150069
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Acuitas Medical, Ltd. have in the registry?
The registry currently lists 1 device for Acuitas Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acuitas Medical, Ltd.'s devices?
Among its 1 most recently registered device, Acuitas Medical, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Acuitas Medical, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Acuitas Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Acuitas Medical, Ltd. in the registry?
The most recently registered devices listed for Acuitas Medical, Ltd. include Fine Structure Analysis(fineSA).