Eli Ezer
2 catalogue numbers from EZ-OPH-1800/LL, listed by U.S. Ophthalmic, L.L.C., under Monitor, Eye Movement. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
Record
| Listed by | U.S. Ophthalmic, L.L.C. |
|---|---|
| FDA product code | HLL |
| Device type | Monitor, Eye Movement |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1510 |
| 510(k) | K052599 |
| Record published | 2016-09-28 |
| Record revised | 2021-05-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EZ-OPH-1800/LL | In distribution | |
| EZ-OPH-1800/HL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Saccadometer | Ober Consulting Sp. Z.O.O. | 2 |
| Retitrack | C. Light Technologies, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.