BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)— 510(k) K231969

Substantially Equivalent

Dongguanshi Yiyingmei Technology Co., Ltd.

FDA 510(k) clearance K231969 for BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808), Substantially Equivalent on 2024-08-30. Applicant: Dongguanshi Yiyingmei Technology Co., Ltd..

Clearance details

Applicant: Dongguanshi Yiyingmei Technology Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2023-07-03
Decision date: 2024-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Donguang, 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.