510(k) K232608

Duo Hands-free Breast Pump by Medela, LLC — Product Code HGX

K232608 is an FDA 510(k) premarket notification submitted by Medela, LLC for the device "Duo Hands-free Breast Pump". The FDA issued a decision of Substantially Equivalent on April 12, 2024. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Medela, LLC has at least 10 other 510(k) clearances on record.