510(k) K190703
K190703 is an FDA 510(k) premarket notification submitted by Neurosoft , Ltd. for the device "Neuro-IOM system with Neuro-IOM.NET software". The FDA issued a decision of Substantially Equivalent on May 22, 2021. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Neurosoft , Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2021
- Date Received
- March 18, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type