K133517 is an FDA 510(k) clearance for the NEMUS 2 SYSTEM. This device is classified as a Amplifier, Physiological Signal (Class II - Special Controls, product code GWL).
Submitted by Eb Neuro S.P.A. (Indianpolis, US). The FDA issued a Cleared decision on February 26, 2014, 103 days after receiving the submission on November 15, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1835.
| 510(k) Number | K133517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2013 |
| Decision Date | February 26, 2014 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWL - Amplifier, Physiological Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1835 |