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FDA 510(k)

Wearable Breast Pump,Model S18

K-Number: K232774 · 2024-06-06

ApplicantNingbo Dearevery Electronic Technology Co., Ltd.
Decision Date2024-06-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Wearable Breast Pump,Model S18 is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Dearevery Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K232774. 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 Wearable Breast Pump,Model S18?

Wearable Breast Pump,Model S18 is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Ningbo Dearevery Electronic Technology Co., Ltd.. The 510(k) number is K232774.

When did Wearable Breast Pump,Model S18 receive FDA 510(k) clearance?

Wearable Breast Pump,Model S18 received FDA 510(k) clearance on 2024-06-06, under 510(k) number K232774.

Who is the listed applicant for Wearable Breast Pump,Model S18?

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

What is the FDA product code for Wearable Breast Pump,Model S18?

The FDA product code for Wearable Breast Pump,Model S18 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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