FDA 510(k)

Yooeehouse Breast Pump

K-Number: K163183 · 2017-10-02

ApplicantNantong Poly Technology Co., Ltd.

Decision Date2017-10-02

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Yooeehouse Breast Pump is a medical device manufactured by Nantong Poly Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-10-02 under approval number K163183. 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 Yooeehouse Breast Pump?

Yooeehouse Breast Pump is a medical device that received FDA 510(k) clearance on 2017-10-02. It is manufactured by Nantong Poly Technology Co., Ltd.. The 510(k) number is K163183.

When was Yooeehouse Breast Pump approved by the FDA?

Yooeehouse Breast Pump received FDA 510(k) clearance on 2017-10-02, under approval number K163183.

What company makes Yooeehouse Breast Pump?

Yooeehouse Breast Pump is manufactured by Nantong Poly Technology Co., Ltd..

What is the FDA product code for Yooeehouse Breast Pump?

The FDA product code for Yooeehouse Breast Pump is HGX.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.