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FDA 510(k)

Evenflo Premium Double Electric Breast Pump (Model 4018)

K-Number: K230481 · 2023-11-03

ApplicantEvenflo Feeding, Inc.
Decision Date2023-11-03
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Evenflo Premium Double Electric Breast Pump (Model 4018) is the device name listed in this FDA 510(k) record. The listed applicant is Evenflo Feeding, Inc.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K230481. 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 Evenflo Premium Double Electric Breast Pump (Model 4018)?

Evenflo Premium Double Electric Breast Pump (Model 4018) is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Evenflo Feeding, Inc.. The 510(k) number is K230481.

When did Evenflo Premium Double Electric Breast Pump (Model 4018) receive FDA 510(k) clearance?

Evenflo Premium Double Electric Breast Pump (Model 4018) received FDA 510(k) clearance on 2023-11-03, under 510(k) number K230481.

Who is the listed applicant for Evenflo Premium Double Electric Breast Pump (Model 4018)?

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

What is the FDA product code for Evenflo Premium Double Electric Breast Pump (Model 4018)?

The FDA product code for Evenflo Premium Double Electric Breast Pump (Model 4018) 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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