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FDA 510(k)

Duo Hands-free Breast Pump

K-Number: K232608 · 2024-04-12

ApplicantMedela, LLC
Decision Date2024-04-12
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Duo Hands-free Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Medela, LLC. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K232608. 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 Duo Hands-free Breast Pump?

Duo Hands-free Breast Pump is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Medela, LLC. The 510(k) number is K232608.

When did Duo Hands-free Breast Pump receive FDA 510(k) clearance?

Duo Hands-free Breast Pump received FDA 510(k) clearance on 2024-04-12, under 510(k) number K232608.

Who is the listed applicant for Duo Hands-free Breast Pump?

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

What is the FDA product code for Duo Hands-free Breast Pump?

The FDA product code for Duo Hands-free Breast Pump is HGX.

Other records listing Medela, LLC 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.

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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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