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FDA 510(k)

Youha electric breast pump

K-Number: K163136 · 2017-07-31

ApplicantNingbo Youhe Electrical Appliance Technology Co., Ltd.
Decision Date2017-07-31
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Youha electric breast pump is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K163136. 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 Youha electric breast pump?

Youha electric breast pump is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. The 510(k) number is K163136.

When did Youha electric breast pump receive FDA 510(k) clearance?

Youha electric breast pump received FDA 510(k) clearance on 2017-07-31, under 510(k) number K163136.

Who is the listed applicant for Youha electric breast pump?

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

What is the FDA product code for Youha electric breast pump?

The FDA product code for Youha electric breast pump is HGX.

Other records listing Ningbo Youhe Electrical Appliance 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.

K251977electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)K242725Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)K203148Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)

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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