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FDA 510(k)

Electric Breast Pump

K-Number: K212564 · 2022-05-06

ApplicantGuangdong Horigen Mother & Baby Products Co., Ltd.
Decision Date2022-05-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Electric Breast Pump is a medical device manufactured by Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under approval number K212564. 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 Electric Breast Pump?

Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K212564.

When was Electric Breast Pump approved by the FDA?

Electric Breast Pump received FDA 510(k) clearance on 2022-05-06, under approval number K212564.

What company makes Electric Breast Pump?

Electric Breast Pump is manufactured by Guangdong Horigen Mother & Baby Products Co., Ltd..

What is the FDA product code for Electric Breast Pump?

The FDA product code for Electric Breast Pump is HGX.

Related Clinical Trials

NCT05746325 Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer RECRUITING

Other Devices by Guangdong Horigen Mother & Baby Products Co., Ltd.

K162747Proture Double Electric Breast Pump K182413Electric Breast Pump K193449Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) K201152Electric Breast Pump K201974Single-use medical face mask

Related Devices (Code: HGX)

K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc. K160274Hi bebe plusBistos Co., Ltd. K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc.

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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