K202588 is an FDA 510(k) clearance for the BNA Platform. This device is classified as a Normalizing Quantitative Electroencephalograph Software (Class II - Special Controls, product code OLU).
Submitted by Elminda, Ltd. (Herzliya, IL). The FDA issued a Cleared decision on December 7, 2020, 90 days after receiving the submission on September 8, 2020.
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 | K202588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2020 |
| Decision Date | December 07, 2020 |
| Days to Decision | 90 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. |