K073415 is an FDA 510(k) clearance for the NEMUS SYSTEM; NEMUS PC PERIPHERAL. This device is classified as a Electromyograph, Diagnostic (Class II - Special Controls, product code IKN).
Submitted by Eb Neuro S.P.A. (Carmel, US). The FDA issued a Cleared decision on May 23, 2008, 171 days after receiving the submission on December 4, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1375.
| 510(k) Number | K073415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2007 |
| Decision Date | May 23, 2008 |
| Days to Decision | 171 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 |