Electric Breast Pump

Pump, Breast, Powered

Zhejiang Carebao Co., Ltd.

The following data is part of a premarket notification filed by Zhejiang Carebao Co., Ltd. with the FDA for Electric Breast Pump.

Pre-market Notification Details

Device IDK211755
510k NumberK211755
Device Name:Electric Breast Pump
ClassificationPump, Breast, Powered
Applicant Zhejiang Carebao Co., Ltd. 3, No.1, Chuangye 4th Road, Ningbo Free Trade Zone Ningbo,  CN 315000
ContactYan Xie
CorrespondentIris Wang
Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue Xili Town Shenzhen,  CN 518000
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-07
Decision Date2021-12-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06973653141687 K211755 000
06973653140314 K211755 000
06973653140284 K211755 000

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