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FDA 510(k)

Electric breast pump (model: M5)

K-Number: K223693 · 2023-03-09

ApplicantShenzhen Lutejiacheng Technology Co., Ltd.
Decision Date2023-03-09
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Electric breast pump (model: M5) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lutejiacheng Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-09 under 510(k) number K223693. 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 (model: M5)?

Electric breast pump (model: M5) is a medical device that received FDA 510(k) clearance on 2023-03-09. The listed applicant is Shenzhen Lutejiacheng Technology Co., Ltd.. The 510(k) number is K223693.

When did Electric breast pump (model: M5) receive FDA 510(k) clearance?

Electric breast pump (model: M5) received FDA 510(k) clearance on 2023-03-09, under 510(k) number K223693.

Who is the listed applicant for Electric breast pump (model: M5)?

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

What is the FDA product code for Electric breast pump (model: M5)?

The FDA product code for Electric breast pump (model: M5) is HGX.

Other records listing Shenzhen Lutejiacheng Technology 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.

K230776Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)K220309Wearable Breast Pump (Model S10)

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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