Youha 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)— 510(k) K203148

Substantially Equivalent

Ningbo Youhe Electrical Appliance Technology Co., Ltd.

FDA 510(k) clearance K203148 for Youha 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), Substantially Equivalent on 2021-07-08. Applicant: Ningbo Youhe Electrical Appliance Technology Co., Ltd..

Clearance details

Applicant
Ningbo Youhe Electrical Appliance Technology Co., Ltd.
Product code
Code HGX
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cixi, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code HGX

product code HGX
Injury
758
Other
2
Total
760

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.