K222838 is an FDA 510(k) clearance for the iSyncBrain©-C. This device is classified as a Normalizing Quantitative Electroencephalograph Software (Class II - Special Controls, product code OLU).
Submitted by iMediSync, Inc. (Seoul, KR). The FDA issued a Cleared decision on March 16, 2023, 177 days after receiving the submission on September 20, 2022.
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 | K222838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2022 |
| Decision Date | March 16, 2023 |
| Days to Decision | 177 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. |