Youha electric breast pump
K-Number: K163136 · 2017-07-31
Decision Date2017-07-31
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Youha electric breast pump is a medical device manufactured by Ningbo Youhe Electrical Appliance Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-07-31 under approval 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. It is manufactured by Ningbo Youhe Electrical Appliance Technology Co., Ltd.. The 510(k) number is K163136.
When was Youha electric breast pump approved by the FDA?
Youha electric breast pump received FDA 510(k) clearance on 2017-07-31, under approval number K163136.
What company makes Youha electric breast pump?
Youha electric breast pump is manufactured by Ningbo Youhe Electrical Appliance Technology Co., Ltd..
What is the FDA product code for Youha electric breast pump?
The FDA product code for Youha electric breast pump is HGX.
Related Clinical Trials
Other Devices by Ningbo Youhe Electrical Appliance Technology Co., Ltd.
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)
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)
Related Devices (Code: HGX)
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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.