SBIClass I
Manual Refractor, 3d Display
21 CFR 886.1770 / Ophthalmic
SBI is the FDA product code for Manual Refractor, 3d Display, a class I device type, regulated under 21 CFR 886.1770. FDA's definition for this code reads: "A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SBI
- Device name
- Manual Refractor, 3d Display
- FDA definition
- A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.
- Regulation
- 21 CFR 886.1770
- Device class
- Class I
- Review panel
- Ophthalmic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SBI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
Applicants with the most clearances
Product code SBI| Applicant | Clearances |
|---|---|
| Evolution Optiks Limited | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code SBI.
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