Single Use Endoscope Valves Set

Endoscope Channel Accessory

Anrei Medical (Hangzhou) Co., Ltd.

The following data is part of a premarket notification filed by Anrei Medical (hangzhou) Co., Ltd. with the FDA for Single Use Endoscope Valves Set.

Pre-market Notification Details

Device IDK192048
510k NumberK192048
Device Name:Single Use Endoscope Valves Set
ClassificationEndoscope Channel Accessory
Applicant Anrei Medical (Hangzhou) Co., Ltd. No. 3 Ave 8, HEDA Hangzhou,  CN 310018
ContactYang Huibing
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. R912, B#15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing,  CN 102401
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-31
Decision Date2020-05-14

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