K053606 is an FDA 510(k) clearance for the BE PLUS / AURA-LTM64 AMPLIFIER. This device is classified as a Amplifier, Physiological Signal (Class II - Special Controls, product code GWL).
Submitted by Eb Neuro S.P.A. (Carmel, US). The FDA issued a Cleared decision on January 24, 2006, 28 days after receiving the submission on December 27, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1835.
| 510(k) Number | K053606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2005 |
| Decision Date | January 24, 2006 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |