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FDA 510(k)

GCE704 Breast Pump

K-Number: K172842 · 2018-06-18

ApplicantGlobalcare
Decision Date2018-06-18
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GCE704 Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Globalcare. It received FDA 510(k) clearance on 2018-06-18 under 510(k) number K172842. 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 GCE704 Breast Pump?

GCE704 Breast Pump is a medical device that received FDA 510(k) clearance on 2018-06-18. The listed applicant is Globalcare. The 510(k) number is K172842.

When did GCE704 Breast Pump receive FDA 510(k) clearance?

GCE704 Breast Pump received FDA 510(k) clearance on 2018-06-18, under 510(k) number K172842.

Who is the listed applicant for GCE704 Breast Pump?

The FDA 510(k) record lists Globalcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GCE704 Breast Pump?

The FDA product code for GCE704 Breast Pump is HGX.

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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