Lung Sound Monitor
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Guangdong: 2 hold an FDA registration. 2 are contract manufacturers.
- Globalcare Medical Technology Co., Ltd. Guangdong, contract manufacturer
- Vistar Medical Supplies Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
The lung sound monitor is intended for use in monitoring and recording lung sounds.
How Is OCR Classified?
Lung Sound Monitor is FDA product code OCR, Class 2, 21 CFR 870.1875.
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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