K232779 is an FDA 510(k) clearance for the QUEX ED. This device is classified as a Reduced- Montage Standard Electroencephalograph (Class II - Special Controls, product code OMC).
Submitted by Qx World, Ltd. (Budapest, HU). The FDA issued a Cleared decision on October 11, 2024, 396 days after receiving the submission on September 11, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes.
| 510(k) Number | K232779 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2023 |
| Decision Date | October 11, 2024 |
| Days to Decision | 396 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OMC - Reduced- Montage Standard Electroencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes |