Yooeehouse Breast Pump— 510(k) K163183

Substantially Equivalent

Nantong Poly Technology Co., Ltd.

FDA 510(k) clearance K163183 for Yooeehouse Breast Pump, Substantially Equivalent on 2017-10-02. Applicant: Nantong Poly Technology Co., Ltd..

Clearance details

Applicant: Nantong Poly Technology Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2016-11-14
Decision date: 2017-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nantong, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.