The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Be Plus / Aura-ltm64 Amplifier.
| Device ID | K053606 |
| 510k Number | K053606 |
| Device Name: | BE PLUS / AURA-LTM64 AMPLIFIER |
| Classification | Amplifier, Physiological Signal |
| Applicant | EB NEURO, S.P.A. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Contact | Carri Graham |
| Correspondent | Carri Graham EB NEURO, S.P.A. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-27 |
| Decision Date | 2006-01-24 |
| Summary: | summary |