EcoVue Sterile and Non-Sterile Ultrasound Gels
K-Number: K181363 · 2018-06-13
ApplicantH R Pharmaceuticals, Inc.
Decision Date2018-06-13
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EcoVue Sterile and Non-Sterile Ultrasound Gels is a medical device manufactured by H R Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2018-06-13 under approval number K181363. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EcoVue Sterile and Non-Sterile Ultrasound Gels?
EcoVue Sterile and Non-Sterile Ultrasound Gels is a medical device that received FDA 510(k) clearance on 2018-06-13. It is manufactured by H R Pharmaceuticals, Inc.. The 510(k) number is K181363.
When was EcoVue Sterile and Non-Sterile Ultrasound Gels approved by the FDA?
EcoVue Sterile and Non-Sterile Ultrasound Gels received FDA 510(k) clearance on 2018-06-13, under approval number K181363.
What company makes EcoVue Sterile and Non-Sterile Ultrasound Gels?
EcoVue Sterile and Non-Sterile Ultrasound Gels is manufactured by H R Pharmaceuticals, Inc..
What is the FDA product code for EcoVue Sterile and Non-Sterile Ultrasound Gels?
The FDA product code for EcoVue Sterile and Non-Sterile Ultrasound Gels is MUI.
Related Clinical Trials
Other Devices by H R Pharmaceuticals, 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.