Nucleus, Ltd.
Country not established
- Devices
- 1
What Nucleus, Ltd. makes
Nucleus, Ltd. manufactures evoked response electrical stimulators, which are devices designed to measure neural activity by delivering controlled electrical stimuli and recording physiological responses. These stimulators are primarily used in clinical and research settings to assess nerve and muscle function, aiding in the diagnosis and evaluation of neurological conditions.
The company’s portfolio is regulated under Class II devices in the United States, with relevant products authorised through the FDA’s 510(k) clearance pathway. These devices are listed in the FDA’s regulatory database, ensuring compliance with applicable medical device standards.
Catalogue
Evoked Response Electrical Stimulator Ref K843226
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nucleus, Ltd. have in the registry?
The registry currently lists 1 device for Nucleus, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nucleus, Ltd.'s devices?
Among its 1 most recently registered device, Nucleus, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Nucleus, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Nucleus, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nucleus, Ltd. in the registry?
The most recently registered devices listed for Nucleus, Ltd. include EVOKED RESPONSE ELECTRICAL STIMULATOR.