The following data is part of a premarket notification filed by Ober Consulting Sp. Z.o.o. with the FDA for Saccadometer Plus, Saccadometer Advanced.
| Device ID | K152890 |
| 510k Number | K152890 |
| Device Name: | SACCADOMETER PLUS, SACCADOMETER ADVANCED |
| Classification | Monitor, Eye Movement |
| Applicant | OBER CONSULTING SP. Z.O.O. BRZECHWY 6 Poznan, PL 60-195 |
| Contact | Jan Krzysztof Ober |
| Correspondent | Jan Krzysztof Ober OBER CONSULTING SP. Z.O.O. BRZECHWY 6 Poznan, PL 60-195 |
| Product Code | HLL |
| CFR Regulation Number | 886.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05906874392027 | K152890 | 000 |
| 05906874392010 | K152890 | 000 |