The following data is part of a premarket notification filed by Apeliotus Vision Science, Inc with the FDA for Adapt, Model Ax-03sn.
| Device ID | K100954 |
| 510k Number | K100954 |
| Device Name: | ADAPT, MODEL AX-03SN |
| Classification | Adaptometer (biophotometer), Software-based Data Acquisition And Stimulus Generation |
| Applicant | APELIOTUS VISION SCIENCE, INC 1456 N. MORNINGSIDE DRIVE, NE Atlanta, GA 30306 |
| Contact | John G Edwards |
| Correspondent | John G Edwards APELIOTUS VISION SCIENCE, INC 1456 N. MORNINGSIDE DRIVE, NE Atlanta, GA 30306 |
| Product Code | OUM |
| CFR Regulation Number | 886.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-07 |
| Decision Date | 2011-02-25 |
| Summary: | summary |