Neurodiagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Neurodiagnostics, Inc. makes
Neurodiagnostics, Inc. manufactures electrodiagnostic devices, including evoked response stimulus generators, electromyography (EMG) systems, and nerve conduction velocity (NCV) testing equipment. Their portfolio covers tools for assessing muscle and nerve function, such as the NDI-IKE EMG unit and specialized systems for evoked response testing. Additional offerings include modular neurodiagnostic platforms designed for clinical use, such as the Neuro Diagnostics Model FCR.
The company’s devices fall under FDA Class II regulation and are recorded in the 510(k) clearance database. Their products are intended for use in the US, where they comply with applicable medical device standards. No other regulatory listings are specified.
Catalogue
Esg-1 (Evoked Response Stimulus Gener) Ref K801671
Regimes: 510(k) Registry: 510(k)Ndi-Ike Emg Ref K801670
Regimes: 510(k) Registry: 510(k)Emg/Ncv & Evoked Response, Design W/ Ref K843253
Regimes: 510(k) Registry: 510(k)Neuro Diagnostics Model Fcr Ref K830191
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Neurodiagnostics, Inc. have in the registry?
The registry currently lists 4 devices for Neurodiagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neurodiagnostics, Inc.'s devices?
Among its 4 most recently registered devices, Neurodiagnostics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Neurodiagnostics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Neurodiagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neurodiagnostics, Inc. in the registry?
The most recently registered devices listed for Neurodiagnostics, Inc. include ESG-1 (EVOKED RESPONSE STIMULUS GENER), NDI-IKE EMG, EMG/NCV & EVOKED RESPONSE, DESIGN W/ and NEURO DIAGNOSTICS MODEL FCR.