Cerebral Oximeter
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Jiangsu: 2 hold an FDA registration. 1 is a contract manufacturer.
- GE Medical Systems (China) Co., Ltd. Jiangsu, contract manufacturer
- Jiangyin Sinbon Electronics Co Ltd Jiangsu, contract manufacturer
What Is This Device?
Oximeter to measure cerebral tissue saturation
How Is QEM Classified?
Cerebral Oximeter is FDA product code QEM, Class 2, 21 CFR 870.2700.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.