The following data is part of a premarket notification filed by Roland Consult with the FDA for Retiscan, Retiport.
| Device ID | K023525 |
| 510k Number | K023525 |
| Device Name: | RETISCAN, RETIPORT |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | ROLAND CONSULT FRIEDRICH-FRANZ-STRASSE 19 Brandenburg, DE D 14770 |
| Contact | Matthias Mai |
| Correspondent | Matthias Mai ROLAND CONSULT FRIEDRICH-FRANZ-STRASSE 19 Brandenburg, DE D 14770 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-21 |
| Decision Date | 2004-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260157780293 | K023525 | 000 |
| 04260157780217 | K023525 | 000 |
| 04260157780224 | K023525 | 000 |
| 04260157780231 | K023525 | 000 |
| 04260157780248 | K023525 | 000 |
| 04260157780255 | K023525 | 000 |
| 04260157780262 | K023525 | 000 |
| 04260157780279 | K023525 | 000 |
| 04260157780286 | K023525 | 000 |
| 04260157780200 | K023525 | 000 |