K212684 is an FDA 510(k) clearance for the BrainView QEEG Software. This device is classified as a Normalizing Quantitative Electroencephalograph Software (Class II - Special Controls, product code OLU).
Submitted by Medeia, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on January 28, 2023, 522 days after receiving the submission on August 24, 2021.
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 | K212684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2021 |
| Decision Date | January 28, 2023 |
| Days to Decision | 522 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. |