510(k) K250070— Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)

Substantially Equivalent

Shenzhen Changkun Technology Co., Ltd.

Clearance details

Applicant: Shenzhen Changkun Technology Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-01-10
Decision date: 2026-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.