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)

Hygeia Express Powered Breast Pump

K-Number: K233136 · 2024-03-13

Decision Date2024-03-13
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Hygeia Express Powered Breast Pump is a medical device manufactured by Hygeia II Medical Group, Inc.. It received FDA 510(k) clearance on 2024-03-13 under approval number K233136. 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 Hygeia Express Powered Breast Pump?

Hygeia Express Powered Breast Pump is a medical device that received FDA 510(k) clearance on 2024-03-13. It is manufactured by Hygeia II Medical Group, Inc.. The 510(k) number is K233136.

When was Hygeia Express Powered Breast Pump approved by the FDA?

Hygeia Express Powered Breast Pump received FDA 510(k) clearance on 2024-03-13, under approval number K233136.

What company makes Hygeia Express Powered Breast Pump?

Hygeia Express Powered Breast Pump is manufactured by Hygeia II Medical Group, Inc..

What is the FDA product code for Hygeia Express Powered Breast Pump?

The FDA product code for Hygeia Express Powered Breast Pump is HGX.

Other Devices by Hygeia II Medical Group, Inc.

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.