ELECTRIC BREAST PUMP— 510(k) K132882

Substantially Equivalent

Shantou Xinghe Electrical Apparatuses Co., Ltd.

FDA 510(k) clearance K132882 for ELECTRIC BREAST PUMP, Substantially Equivalent on 2014-04-24. Applicant: Shantou Xinghe Electrical Apparatuses Co., Ltd..

Clearance details

Applicant: Shantou Xinghe Electrical Apparatuses Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2013-09-13
Decision date: 2014-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, Guangdong, CN

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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.