Neurosoft Ltd
Ivanovo Ivanovskaya Oblast', RU
NEUROSOFT LTD appears in FDA device records in Ivanovo Ivanovskaya Oblast', RU. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Neurosoft Ltd between 2000 and 2022. The busiest year on record is 2000, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2001 | 2 |
| 2015 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | OLT | Substantially Equivalent | |
| K190703 | Neuro-IOM system with Neuro-IOM.NET software | GWF | Substantially Equivalent | |
| K133995 | NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE | OLT | Substantially Equivalent | |
| K011241 | NEUROSOFT'S SOURCE | OLX | Substantially Equivalent | |
| K001781 | CURRY MULTIMODAL NEUROIMAGING SOFTWARE | OLX | Substantially Equivalent | |
| K001692 | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 | JXE | Substantially Equivalent | |
| K000812 | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) | IKN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006418479 | 3006418479 | NEUROSOFT LTD | 5 Voronin Street, Ivanovo Ivanovskaya Oblast' 153009 RU | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EWOAudiometer
- HCCDevice, Biofeedback
- JXEDevice, Nerve Conduction Velocity Measurement
- IKNElectromyograph, Diagnostic
- GWQFull-Montage Standard Electroencephalograph
- PDQNeurosurgical Nerve Locator
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph
- OLVStandard Polysomnograph With Electroencephalograph
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- GWEStimulator, Photic, Evoked Response
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- OBPTranscranial Magnetic Stimulator
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- PTPTympanometer, Exempt
- EXYUroflowmeter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain