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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is H R Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) 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. The listed applicant is H R Pharmaceuticals, Inc.. The 510(k) number is K181363.

When did EcoVue Sterile and Non-Sterile Ultrasound Gels receive FDA 510(k) clearance?

EcoVue Sterile and Non-Sterile Ultrasound Gels received FDA 510(k) clearance on 2018-06-13, under 510(k) number K181363.

Who is the listed applicant for EcoVue Sterile and Non-Sterile Ultrasound Gels?

The FDA 510(k) record lists H R Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing H R Pharmaceuticals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200556AquaFlate Pre-Filled Sterile Water Syringe 10mL

Related Devices (Code: MUI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd.K252337EdgeFlow Gel PadEdgecare, Inc.K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.K221999Ultrasound Transmission GelsHony Medical Co., Ltd.

Official Source

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

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