In the US, FDA clearance is required prior to the sales and marketing of medical devices.
Neurosoft medical devices listed below are cleared by the FDA.
|2-Channel Portable EMG, NCS and EP System Focus||Focus brochure
|Transcranial Magnetic Stimulator CloudTMS||CloudTMS website||Approval letter
|12-channel Miniature Wireless ECG System CloudEKG||CloudEKG brochure||Approval letter
Clinical ABR&OAE Analyzer, Screening Audiometer Neuro-Audio
|Neuro-Audio brochure||Approval letter
|Digital EEG System Series Neuron-Spectrum-1, 2, 3, 4, 4/P||Neuron-Spectrum brochure||Approval letter
Uses other than listed in the Device’s Intended Use as outlined in the 510(k) summary have not been cleared by the FDA and should be considered for Investigational Use only.
Products manufactured by Neurosoft that have not been cleared by the FDA are considered Investigational Devices and are subject to Investigational Device Exemption (IDE) and Institutional Review Board (IRB) review before their use.
All questions regarding the FDA clearance of Neurosoft medical devices, IDE and IRB should be directed to korkishko neurosoft.ru (Anna Semenova) , engineer of Neurosoft’s Quality Assurance and Regulatory Affairs department.
For more information, you may also consult the FDA website at: http://fda.gov/