Kowa Applanation Tonometer HA-2
For the measurement of intraocular pressure in the diagnosis of glaucoma.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Beijing (1), Shanghai (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 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
Record
| Listed by | Kowa Co., Ltd., Japan |
|---|---|
| FDA product code | HKY |
| Device type | Tonometer, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1930 |
| 510(k) | K960924 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -15 to 60 °C; Storage environment humidity 10 to 95 % RH; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 75 % RH |
| Sizes | Weight 240 g; length 290 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ATO-6K | Weight 240 g | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tonometer AT 900 | Haag-Streit AG | 7 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Ocu-Film® +” | Reichert Inc. | 5 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 5 |
| AccuTip Cover | Accutome, Inc. | 4 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 4 |
| Applanation Tonometer | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 3 |
| Icare ic200 | Icare Finland Oy | 3 |
| Marco | Takagi Seiko Co., Ltd. | 2 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 2 |
| iCare PATIENT2 | Icare Finland Oy | 2 |
| Tonometer AT 870 | Haag-Streit AG | 2 |
Showing 12 of 71. All products under Tonometer, Manual
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.