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FDA 510(k)

MilkMate Breast Pump

K-Number: K223084 · 2023-03-16

ApplicantMilkmate Products, Inc.
Decision Date2023-03-16
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MilkMate Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Milkmate Products, Inc.. It received FDA 510(k) clearance on 2023-03-16 under 510(k) number K223084. 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 MilkMate Breast Pump?

MilkMate Breast Pump is a medical device that received FDA 510(k) clearance on 2023-03-16. The listed applicant is Milkmate Products, Inc.. The 510(k) number is K223084.

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

MilkMate Breast Pump received FDA 510(k) clearance on 2023-03-16, under 510(k) number K223084.

Who is the listed applicant for MilkMate Breast Pump?

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

What is the FDA product code for MilkMate Breast Pump?

The FDA product code for MilkMate Breast Pump is HGX.

Other records listing Milkmate Products, Inc. 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.

K241705MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)

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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