Humphrey Field Analyzer (HFA3)
The Humphrey Field Analyzer is an automated perimeter intended to identify visual field defects for the purposes of screening, monitoring and assisting in the diagnosis of ocular and…
The Humphrey Field Analyzer is an automated perimeter intended to identify visual field defects for the purposes of screening, monitoring and assisting in the diagnosis of ocular and neurological disorders including glaucoma.
Who Else Makes It
Concentrated in Chongqing (4), Jiangsu (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
| Main Meditech Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 3 |
| Chongqing SS Medical Equipments Co., Ltd. | Chongqing | Chongqing | Manufacturer | 3 |
Record
| Listed by | Carl Zeiss Meditec Inc, United States |
|---|---|
| FDA product code | HPT |
| Device type | Perimeter, Automatic, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1605 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-11 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 860 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perimeter | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 7 |
| Perimeter, Automatic, Ac-Powered | Chongqing Kanghuaruiming S&T Co., Ltd.. | 7 |
| Automated Perimeter | Optopol Technology SP Z O O | 5 |
| Virtual Field | Virtual Field, Inc | 4 |
| Humphrey Field Analyzer 3 (HFA3) | Carl Zeiss Meditec Inc | 4 |
| Carrot | Virtual Field, Inc | 3 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 2 |
| SYL | Chongqing SS Medical Equipments Co., Ltd. | 2 |
| VisionOne | PeriVision SA | 2 |
| RetinaLogik | Retinalogik Inc. | 2 |
| Maia | Centervue | 2 |
| Medmont Automated Perimeter DAC | Medmont International PTY Ltd | 1 |
Showing 12 of 34. All products under Perimeter, Automatic, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093213 | 2010-03-12 |
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.