Nebulizer Kit

Nebulizer (direct Patient Interface)

Excellentcare Medical (Huizhou) Ltd.

The following data is part of a premarket notification filed by Excellentcare Medical (huizhou) Ltd. with the FDA for Nebulizer Kit.

Pre-market Notification Details

Device IDK192971
510k NumberK192971
Device Name:Nebulizer Kit
ClassificationNebulizer (direct Patient Interface)
Applicant Excellentcare Medical (Huizhou) Ltd. Shatou Industrial Zone. Yuanzhou Town. Huizhou,  CN 516123
ContactChunyu Zhao
CorrespondentElly Xu
Shenzhen Joyantech Consulting Co., Ltd. NO. 55 Shizhou Middle Road, Nanshan District Shenzhen,  CN 518000
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-23
Decision Date2021-07-08

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