Axon Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 15
What Axon Systems, Inc. makes
Axon Systems, Inc. manufactures neurological monitoring and stimulation devices, including dual-channel stimulators, disposable monopolar and bipolar stimulator probes, and EEG analyzers like the Sentinel 4 and Phoenix Digital EEG. Their portfolio also includes neurological workstations (e.g., Epoch 2000, Epoch XP), transcranial Doppler (TCD) neurovascular workstations (e.g., Eclipse), ambulatory EEG systems, and surface electrodes such as Sunspots pre-gelled electrodes. Stimulus/dissection instruments and specialized software/hardware upgrades for existing systems are also part of their offerings.
These devices are classified under FDA Class II, requiring premarket notification (510(k)) clearance. Axon Systems, Inc. is based in the United States, with their products listed in the FDA’s 510(k) registry.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Axon Systems, Inc. have in the registry?
The registry currently lists 15 devices for Axon Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Axon Systems, Inc.'s devices?
Among its 15 most recently registered devices, Axon Systems, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Axon Systems, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Axon Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Axon Systems, Inc. in the registry?
The most recently registered devices listed for Axon Systems, Inc. include SS102 DUAL CHANNEL SEP STIMULATOR, DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES, ORTHOMON and SENTINEL 4 EEG ANALYZER.