K173936 is an FDA 510(k) clearance for the Natus Photic Stimulator. This device is classified as a Stimulator, Photic, Evoked Response (Class II - Special Controls, product code GWE).
Submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on June 15, 2018, 171 days after receiving the submission on December 26, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1890.
| 510(k) Number | K173936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2017 |
| Decision Date | June 15, 2018 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWE - Stimulator, Photic, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1890 |