Reader, Bar, Ophthalmic
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Zhejiang.
How Is HJY Classified?
Reader, Bar, Ophthalmic is FDA product code HJY, Class 1, 21 CFR 886.5800.
How Does It Reach the US Market?
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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