Evolve Breast Pump
K-Number: K200406 · 2020-03-18
ApplicantHygeia II Medical Group, Inc.
Decision Date2020-03-18
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Evolve Breast Pump is a medical device manufactured by Hygeia II Medical Group, Inc.. It received FDA 510(k) clearance on 2020-03-18 under approval number K200406. 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 Evolve Breast Pump?
Evolve Breast Pump is a medical device that received FDA 510(k) clearance on 2020-03-18. It is manufactured by Hygeia II Medical Group, Inc.. The 510(k) number is K200406.
When was Evolve Breast Pump approved by the FDA?
Evolve Breast Pump received FDA 510(k) clearance on 2020-03-18, under approval number K200406.
What company makes Evolve Breast Pump?
Evolve Breast Pump is manufactured by Hygeia II Medical Group, Inc..
What is the FDA product code for Evolve Breast Pump?
The FDA product code for Evolve Breast Pump is HGX.
Other Devices by Hygeia II Medical Group, Inc.
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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.