K172743 is an FDA 510(k) clearance for the Natus VikingQuest. This device is classified as a Electromyograph, Diagnostic (Class II - Special Controls, product code IKN).
Submitted by Natus Neurology Incorporated (Middleton, US). The FDA issued a Cleared decision on December 19, 2017, 98 days after receiving the submission on September 12, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1375.
| 510(k) Number | K172743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2017 |
| Decision Date | December 19, 2017 |
| Days to Decision | 98 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IKN - Electromyograph, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1375 |