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FDA 510(k)

Proture Double Electric Breast Pump

K-Number: K162747 · 2016-12-08

ApplicantGuangdong Horigen Mother & Baby Products Co., Ltd.
Decision Date2016-12-08
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Proture Double Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K162747. 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 Proture Double Electric Breast Pump?

Proture Double Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K162747.

When did Proture Double Electric Breast Pump receive FDA 510(k) clearance?

Proture Double Electric Breast Pump received FDA 510(k) clearance on 2016-12-08, under 510(k) number K162747.

Who is the listed applicant for Proture Double Electric Breast Pump?

The FDA 510(k) record lists Guangdong Horigen Mother & Baby Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proture Double Electric Breast Pump?

The FDA product code for Proture Double Electric Breast Pump is HGX.

Other records listing Guangdong Horigen Mother & Baby Products 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.

K212564Electric Breast PumpK201152Electric Breast PumpK201974Single-use medical face maskK193449Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)K182413Electric Breast Pump

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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