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FDA 510(k)

Electric Breast Pump

K-Number: K211755 · 2021-12-01

ApplicantZhejiang Carebao Co., Ltd.
Decision Date2021-12-01
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Carebao Co., Ltd.. It received FDA 510(k) clearance on 2021-12-01 under 510(k) number K211755. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electric Breast Pump?

Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Zhejiang Carebao Co., Ltd.. The 510(k) number is K211755.

When did Electric Breast Pump receive FDA 510(k) clearance?

Electric Breast Pump received FDA 510(k) clearance on 2021-12-01, under 510(k) number K211755.

Who is the listed applicant for Electric Breast Pump?

The FDA 510(k) record lists Zhejiang Carebao Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Breast Pump?

The FDA product code for Electric Breast Pump is HGX.

Other records listing Zhejiang Carebao Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222782Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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