Omega 600 Wired
Catalogue number 000, listed by Heine Optotechnik Gmbh & Co. KG., Germany, under Ophthalmoscope, Ac-Powered. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (1), Jiangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Raish Meditech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Jiang XI BIG Vision Medical Technology Co., Ltd. | Ganzhou | Jiangxi | Manufacturer | 3 |
| Robotrak Technologies Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Heine Optotechnik Gmbh & Co. KG., Germany |
|---|---|
| FDA product code | HLI |
| Device type | Ophthalmoscope, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1570 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-01-13 |
| Record revised | 2021-02-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 90 |
| Amico Diagnostic Station | Amico Diagnostic Incorporated | 55 |
| iVue | Optovue, Inc. | 27 |
| Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 19 |
| Amico Diagnostic Rollstand | Amico Diagnostic Incorporated | 14 |
| iScan | Optovue, Inc. | 7 |
| zumax | Zumax Medical Co., Ltd. | 6 |
| Jedmed | Jedmed Instrument Company | 3 |
| RTVue XR Avanti | Optovue, Inc. | 3 |
| Amico Diagnostic Ophthalmoscope | Amico Diagnostic Incorporated | 3 |
| Laser Speckle Flowgraphy Lsfg-Navi | Softcare Co., Ltd. | 2 |
| Panoramic Ophthalmoscope | Optos Public Limited Company | 1 |
Showing 12 of 46. All products under Ophthalmoscope, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123316 | 2013-02-26 |
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.