System, Reading, Television, Closed-Circuit
Which Manufacturers in China Make This?
4 manufacturers in China hold an FDA registration for this device type, based in Zhejiang and Beijing.
- Beijing Hongdee Corporation Beijing
- Shaoxing Undis Medical Technology Company Limited Zhejiang
- Wenzhou Topsight Eyewear Co., Ltd. Zhejiang
- Zoomax Technology Co., Limited Zhejiang, contract manufacturer
What Is FDA Product Code HJG?
System, Reading, Television, Closed-Circuit is FDA product code HJG, Class 1, 21 CFR 886.5820.
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.
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