The following data is part of a premarket notification filed by Globalcare Medical Technology Co., Ltd. with the FDA for Gus831 Compressor Nebulizer.
|Device Name:||GUS831 Compressor Nebulizer|
|Classification||Nebulizer (direct Patient Interface)|
|Applicant||Globalcare Medical Technology Co., Ltd. 7th Building, 39 Middle Industrial Main Road, European Industrial Zone Xiaolan Town, Zhongshan City, CN 528415|
Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, Nanshan Medical Device Industrial Park, Nanshan District Shenzhen, CN 518067
|CFR Regulation Number||868.5630 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|