The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Sandman Sd20 Amplifier.
| Device ID | K040113 |
| 510k Number | K040113 |
| Device Name: | SANDMAN SD20 AMPLIFIER |
| Classification | Amplifier, Physiological Signal |
| Applicant | EB NEURO, S.P.A. 7992 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Colleen Densmore |
| Correspondent | Colleen Densmore EB NEURO, S.P.A. 7992 CASTLEWAY DR. Indianapolis, IN 46250 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-20 |
| Decision Date | 2004-02-18 |
| Summary: | summary |