Evaporator
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Shandong, Hong Kong and Shanghai: 4 hold an FDA registration.
- Infitek Co., Ltd. Shanghai
- Labpeak Co., Ltd. Shandong
- Leader Light Limited Hong Kong
- Scitek Global Co., Ltd. Shandong
What Is FDA Product Code JRK?
Evaporator is FDA product code JRK, Class 1, 21 CFR 862.2050.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.
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