Electric Breast Pump (F5055)— 510(k) K240218

Substantially Equivalent

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

FDA 510(k) clearance K240218 for Electric Breast Pump (F5055), Substantially Equivalent on 2024-10-17. Applicant: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd..

Clearance details

Applicant: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2024-01-26
Decision date: 2024-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.