Evenflo Premium Double Electric Breast Pump (Model 4018)— 510(k) K230481

Substantially Equivalent

Evenflo Feeding, Inc.

FDA 510(k) clearance K230481 for Evenflo Premium Double Electric Breast Pump (Model 4018), Substantially Equivalent on 2023-11-03. Applicant: Evenflo Feeding, Inc..

Clearance details

Applicant: Evenflo Feeding, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2023-02-22
Decision date: 2023-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, OH, US

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.