OUM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1050
- Medical specialty
- Ophthalmic
- FDA definition
- Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.
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| Record | Firm | Date |
|---|---|---|
| ADAPT, MODEL AX-03SN (K100954) | Apeliotus Vision Science, Inc. | 2011-02-25 |
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Every clearance here is in the API, with alerts when new ones post.