K183529 is an FDA 510(k) clearance for the AE-120A EEG Head Set. This device is classified as a Reduced- Montage Standard Electroencephalograph (Class II - Special Controls, product code OMC).
Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on March 19, 2019, 90 days after receiving the submission on December 19, 2018.
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 | K183529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2018 |
| Decision Date | March 19, 2019 |
| 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 |