Electric Breast Pump

Pump, Breast, Powered

Ningbo Huiyoo Baby Products Co. Ltd.

The following data is part of a premarket notification filed by Ningbo Huiyoo Baby Products Co. Ltd. with the FDA for Electric Breast Pump.

Pre-market Notification Details

Device IDK191802
510k NumberK191802
Device Name:Electric Breast Pump
ClassificationPump, Breast, Powered
Applicant Ningbo Huiyoo Baby Products Co. Ltd. 523# Cizhang Road, Zhangqi Industrial Area Cixi,  CN 315313
ContactXiaoping Liu
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai,  CN 200120
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
510k Review PanelObstetrics/Gynecology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-03
Decision Date2020-01-16

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