Evolve Breast Pump
K-Number: K190465 · 2019-10-18
ApplicantHygeia II Medical Group, Inc.
Decision Date2019-10-18
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 2019-10-18 under approval number K190465. 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 2019-10-18. It is manufactured by Hygeia II Medical Group, Inc.. The 510(k) number is K190465.
When was Evolve Breast Pump approved by the FDA?
Evolve Breast Pump received FDA 510(k) clearance on 2019-10-18, under approval number K190465.
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.