K203827 is an FDA 510(k) clearance for the REMI. This device is classified as a Reduced- Montage Standard Electroencephalograph (Class II - Special Controls, product code OMC).
Submitted by Epitel, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 29, 2021, 90 days after receiving the submission on December 29, 2020.
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 | K203827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2020 |
| Decision Date | March 29, 2021 |
| Days to Decision | 90 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 |