GUS831 Compressor Nebulizer

Nebulizer (direct Patient Interface)

Globalcare Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Globalcare Medical Technology Co., Ltd. with the FDA for Gus831 Compressor Nebulizer.

Pre-market Notification Details

Device IDK192633
510k NumberK192633
Device Name:GUS831 Compressor Nebulizer
ClassificationNebulizer (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
ContactJanice Deng
CorrespondentKevin Wang
Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, Nanshan Medical Device Industrial Park, Nanshan District Shenzhen,  CN 518067
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-23
Decision Date2020-05-01

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