Marco
2 catalogue numbers from MARCO AT-8 APPLANATION TONOMETER, listed by Takagi Seiko Co., Ltd., Japan, under Tonometer, Manual. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Takagi Seiko Co., Ltd., Japan |
|---|---|
| FDA product code | HKY |
| Device type | Tonometer, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1930 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K182491 |
| Record published | 2019-01-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MARCO AT-8 APPLANATION TONOMETER | In distribution | |
| MARCO AT-9 APPLANATION TONOMETER | 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 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 2 |
| iCare PATIENT2 | Icare Finland Oy | 2 |
| Tonometer AT 870 | Haag-Streit AG | 2 |
| Takagi | Takagi Seiko Co., Ltd. | 2 |
Showing 12 of 71. All products under Tonometer, Manual
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182491 | 2018-12-10 |
| K172728 | 2017-10-17 |
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.