Continuous Ventilator, Minimal Ventilatory Support
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Guangdong and Hunan: 3 hold an FDA registration.
- Guangzhou Hypnus Healthcare Co., Ltd. Guangdong
- Hunan Beyond Medical Technology Co., Ltd. Hunan, contract manufacturer
- Resvent Medical Technology Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
A continuous ventilator (respirator) for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency.
How Is QOR Classified?
Continuous Ventilator, Minimal Ventilatory Support is FDA product code QOR, not classified.
How Does It Reach the US Market?
This code was created for emergency use authorisation during the COVID-19 public health emergency; sale under it depended on the authorisation, not on a standard premarket submission.
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