K232608

Substantially Equivalent

Duo Hands-free Breast Pump

Applicant
Medela, LLC
Product code
HGX
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mchenry, IL, 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, through . 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.