The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Be Plus Ltm Amplifier Gwi Amplifier.
| Device ID | K121996 |
| 510k Number | K121996 |
| Device Name: | BE PLUS LTM AMPLIFIER GWI AMPLIFIER |
| Classification | Amplifier, Physiological Signal |
| Applicant | EB NEURO, S.P.A. 9001 WESLEYAN ROAD Indianapolis, IN 46268 |
| Contact | Allison Scott |
| Correspondent | Allison Scott EB NEURO, S.P.A. 9001 WESLEYAN ROAD Indianapolis, IN 46268 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-09 |
| Decision Date | 2012-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056446900178 | K121996 | 000 |
| 08056446900086 | K121996 | 000 |
| 08056446900093 | K121996 | 000 |
| 08056446900109 | K121996 | 000 |
| 08056446900116 | K121996 | 000 |
| 08056446900123 | K121996 | 000 |
| 08056446900130 | K121996 | 000 |
| 08056446900147 | K121996 | 000 |
| 08056446900154 | K121996 | 000 |
| 08056446900161 | K121996 | 000 |
| 08056446900079 | K121996 | 000 |