OUM — Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation Class I
FDA product code OUM covers "Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation", a Class I medical device regulated under 21 CFR 886.1050. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OUM
- Device Class
- Class I
- Regulation Number
- 886.1050
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K100954 | apeliotus vision science | ADAPT, MODEL AX-03SN | February 25, 2011 |