Neuro-IOM system with Neuro-IOM.NET software
FDA 510(k) K190703 · Neurosoft , Ltd.
510(k) numberK190703
Submission
- Device name
- Neuro-IOM system with Neuro-IOM.NET software
- Applicant
- Neurosoft , Ltd.
Ivanovo, RU - Received
- March 18, 2019
- Decision date
- May 22, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K001781 | Curry Multimodal Neuroimaging SoftwareOLX · Traditional | 02/05/2001SE |
| K001692 | Neuro Scan Medical Ststems, Model Medicor 8JXE · Traditional | 11/24/2000SE |
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Questions and answers
When was Neuro-IOM system with Neuro-IOM.NET software cleared by the FDA?
Neuro-IOM system with Neuro-IOM.NET software (K190703) received a 510(k) decision of Substantially Equivalent on May 22, 2021, 796 days after the submission was received.
What is the product code of K190703?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.