FDA 510(k)

EcoVue 無菌および非无菌超音波ジェル

K番号: K181363 · 2018-06-13

決定日2018-06-13

製品コードMUI

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてH R Pharmaceuticals, Inc.を記載するその他の記録

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