K173460 is an FDA 510(k) clearance for the NeuroEEG. This device is classified as a Full-montage Standard Electroencephalograph (Class II - Special Controls, product code GWQ).
Submitted by Memory MD, Inc. (New York, US). The FDA issued a Cleared decision on February 16, 2018, 101 days after receiving the submission on November 7, 2017.
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 Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations.
| 510(k) Number | K173460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2017 |
| Decision Date | February 16, 2018 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWQ - Full-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 Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations |