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FDA_for_US_customers

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
US website
Approval letter
k102610
Transcranial Magnetic Stimulator  CloudTMS CloudTMS website Approval letter
k160309
12-channel Miniature Wireless ECG System CloudEKG CloudEKG brochure Approval letter
k130878

Clinical ABR&OAE Analyzer, Screening Audiometer       Neuro-Audio

Neuro-Audio brochure Approval letter
k141524
Digital EEG System Series Neuron-Spectrum-1, 2, 3, 4, 4/P Neuron-Spectrum brochure Approval letter
k133995

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/