K162199 is an FDA 510(k) clearance for the Cascade IOMAX Intraoperative Monitor. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on March 2, 2017, 209 days after receiving the submission on August 5, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K162199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2016 |
| Decision Date | March 02, 2017 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWF - Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |