K162383 is an FDA 510(k) clearance for the Cadwell Sierra Summit, Cadwell Sierra Ascent. This device is classified as a Electromyograph, Diagnostic (Class II - Special Controls, product code IKN).
Submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on March 1, 2017, 188 days after receiving the submission on August 25, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1375.
| 510(k) Number | K162383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2016 |
| Decision Date | March 01, 2017 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IKN - Electromyograph, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1375 |