Humphrey FDT is an AC-powered device intended to determine the extent of the peripheral visual field of a patient. The device is intended to determine the amount of visual field loss in a…
Humphrey FDT is an AC-powered device intended to determine the extent of the peripheral visual field of a patient. The device is intended to determine the amount of visual field loss in a patient, which can then be used to diagnose/track the progression of glaucoma and other eye diseases.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for Humphrey FDT | Listed by | Carl Zeiss Meditec Inc, United States |
| FDA product code | HOO |
| Device type | Perimeter, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1605 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-13 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Latex | Labelled latex-free |
| Distribution end date | 2018-06-13 |
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.