K221563 is an FDA 510(k) clearance for the Neurosteer EEG Recorder. This device is classified as a Reduced- Montage Standard Electroencephalograph (Class II - Special Controls, product code OMC).
Submitted by Neurosteer, Inc. (New York, US). The FDA issued a Cleared decision on October 24, 2022, 146 days after receiving the submission on May 31, 2022.
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 | K221563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2022 |
| Decision Date | October 24, 2022 |
| Days to Decision | 146 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 |