VistOR EX LED
MI-500 Examination Light, Single Ceiling
18manufacturers in China registered for this device type
8catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Guangdong (5), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Hongbo Optical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 12 |
| Zhongshan Meiyigou Electronics Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 11 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
Showing 12 of 18. All 18 manufacturers in China registered for Device, Medical Examination, Ac Powered
Record
| Listed by | Medical Illumination International, Inc, United States |
|---|---|
| FDA product code | KZF |
| Device type | Device, Medical Examination, Ac Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6320 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2024-04-15 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NV061313 | In distribution | |
| NV061322 | In distribution | |
| NV061315 | In distribution | |
| NV061314 | In distribution | |
| NV061324 | In distribution | |
| NV061325 | In distribution | |
| NV061312 | In distribution | |
| NV061323 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Celestial Star | Sunnex, Inc. | 27 |
| ACEMST1 | Acem SPA | 22 |
| HexaLux | Steris Corporation | 18 |
| Vista LED | Avante | 16 |
| MI Product Line | Medical Illumination International, Inc | 16 |
| Tri Star | Sunnex, Inc. | 14 |
| Verilux | Bear Down Consulting | 14 |
| Midmark | Midmark Corporation | 14 |
| Ritter | Midmark Corporation | 13 |
| PF | Sunnex, Inc. | 13 |
| Kenex | Kenex (Electro-Medical) Ltd. | 13 |
| Lucea LED® | Maquet Gmbh | 12 |
Showing 12 of 63. All products under Device, Medical Examination, Ac Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K931646 | 1993-08-19 |
| K931026 | 1993-08-19 |
| K925710 | 1993-06-04 |
| K922278 | 1993-03-04 |
| K922282 | 1993-03-04 |
| K922280 | 1993-02-05 |
| K922281 | 1993-02-05 |
| K922277 | 1993-02-05 |
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.