K142624 is an FDA 510(k) clearance for the Neuromaster G1 MEE200. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on April 24, 2015, 220 days after receiving the submission on September 16, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K142624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2014 |
| Decision Date | April 24, 2015 |
| Days to Decision | 220 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 |