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FDA 510(k)

Powered Breast Pump (Models 7V and 7X)

K-Number: K211016 · 2022-06-29

ApplicantHaenim Co., Ltd.
Decision Date2022-06-29
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Powered Breast Pump (Models 7V and 7X) is the device name listed in this FDA 510(k) record. The listed applicant is Haenim Co., Ltd.. It received FDA 510(k) clearance on 2022-06-29 under 510(k) number K211016. 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 Powered Breast Pump (Models 7V and 7X)?

Powered Breast Pump (Models 7V and 7X) is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Haenim Co., Ltd.. The 510(k) number is K211016.

When did Powered Breast Pump (Models 7V and 7X) receive FDA 510(k) clearance?

Powered Breast Pump (Models 7V and 7X) received FDA 510(k) clearance on 2022-06-29, under 510(k) number K211016.

Who is the listed applicant for Powered Breast Pump (Models 7V and 7X)?

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

What is the FDA product code for Powered Breast Pump (Models 7V and 7X)?

The FDA product code for Powered Breast Pump (Models 7V and 7X) 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

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

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