The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Galileo Nt.
| Device ID | K142064 |
| 510k Number | K142064 |
| Device Name: | GALILEO NT |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | EB NEURO, S.P.A. 9001 WESLEYAN RD, STE 200 Indianapolis, IN 46268 |
| Contact | Allison Scott, Rac |
| Correspondent | Allison Scott, Rac EB NEURO, S.P.A. 9001 WESLEYAN RD, STE 200 Indianapolis, IN 46268 |
| Product Code | OLT |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JXE |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-30 |
| Decision Date | 2015-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056446900642 | K142064 | 000 |