Tester, Electrode/Lead, Electroencephalograph
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Shandong and Zhejiang.
- China Qingdao Bright Medical Manufacturing Co., Ltd. Shandong, contract manufacturer
- WAT Medical Technology Inc. Zhejiang
How Is GYA Classified?
Tester, Electrode/Lead, Electroencephalograph is FDA product code GYA, Class 1, 21 CFR 882.1410.
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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