The following data is part of a premarket notification filed by Verisci Corporation with the FDA for Neucodia.
| Device ID | K081591 |
| 510k Number | K081591 |
| Device Name: | NEUCODIA |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | VERISCI CORPORATION 106 ANDERSON STREET Raritan, NJ 08869 -1514 |
| Contact | George Hu |
| Correspondent | George Hu VERISCI CORPORATION 106 ANDERSON STREET Raritan, NJ 08869 -1514 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-06 |
| Decision Date | 2009-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582275270020 | K081591 | 000 |