The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Mizar, Basis Be, Sandman Digital.
| Device ID | K003154 |
| 510k Number | K003154 |
| Device Name: | MIZAR, BASIS BE, SANDMAN DIGITAL |
| Classification | Amplifier, Physiological Signal |
| Applicant | EB NEURO, S.P.A. 7992 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Colleen Hittle |
| Correspondent | Colleen Hittle EB NEURO, S.P.A. 7992 CASTLEWAY DR. Indianapolis, IN 46250 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2001-01-05 |