K240420 is an FDA 510(k) clearance for the NeuroField Analysis Suite. This device is classified as a Normalizing Quantitative Electroencephalograph Software (Class II - Special Controls, product code OLU).
Submitted by Neurofield, Inc. (Bishop, US). The FDA issued a Cleared decision on September 20, 2024, 220 days after receiving the submission on February 13, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User..
| 510(k) Number | K240420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2024 |
| Decision Date | September 20, 2024 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLU - Normalizing Quantitative Electroencephalograph Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User. |