Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Duo Hands-free Breast Pump

K-Number: K232608 · 2024-04-12

ApplicantMedela, LLC
Decision Date2024-04-12
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Duo Hands-free Breast Pump is a medical device manufactured by Medela, LLC. It received FDA 510(k) clearance on 2024-04-12 under approval number K232608. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Duo Hands-free Breast Pump?

Duo Hands-free Breast Pump is a medical device that received FDA 510(k) clearance on 2024-04-12. It is manufactured by Medela, LLC. The 510(k) number is K232608.

When was Duo Hands-free Breast Pump approved by the FDA?

Duo Hands-free Breast Pump received FDA 510(k) clearance on 2024-04-12, under approval number K232608.

What company makes Duo Hands-free Breast Pump?

Duo Hands-free Breast Pump is manufactured by Medela, LLC.

What is the FDA product code for Duo Hands-free Breast Pump?

The FDA product code for Duo Hands-free Breast Pump is HGX.

Related Clinical Trials

Other Devices by Medela, LLC

View all 7 devices →

Related Devices (Code: HGX)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.