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FDA 510(k)

Electric Breast Pump

K-Number: K231595 · 2023-10-26

ApplicantShenzhen Changkun Technology Co., Ltd.
Decision Date2023-10-26
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Electric Breast Pump is a medical device manufactured by Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-26 under approval number K231595. 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 2023-10-26. It is manufactured by Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K231595.

When was Electric Breast Pump approved by the FDA?

Electric Breast Pump received FDA 510(k) clearance on 2023-10-26, under approval number K231595.

What company makes Electric Breast Pump?

Electric Breast Pump is manufactured by Shenzhen Changkun Technology 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 Shenzhen Changkun Technology Co., Ltd.

K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 K193386Wrist Electronic Sphygmomanometer K193387Arm Electronic Sphygmomanometer K221798Finger Pulse Oximeter, Model: X1906P K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)

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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