Equipment, Photographic, for Physiologic Function Monitor
Who Makes This Device Type in China?
3 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Anhui.
- Anhui Shiyin Photoelectric Instrument Co., Ltd. Anhui
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- Xuzhou Hengjia Electronic Technology Co., Ltd. Jiangsu
What Is FDA Product Code EXZ?
Equipment, Photographic, For Physiologic Function Monitor is FDA product code EXZ, Class 1, 21 CFR 876.1500.
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.
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