K181466 is an FDA 510(k) clearance for the Cadwell Zenith System. This device is classified as a Full-montage Standard Electroencephalograph (Class II - Special Controls, product code GWQ).
Submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on September 1, 2018, 89 days after receiving the submission on June 4, 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 Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations.
| 510(k) Number | K181466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2018 |
| Decision Date | September 01, 2018 |
| Days to Decision | 89 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 |