FDA 510(k)

ソニシールド100 抗菌超音波ジェル

K番号: K151070 · 2016-01-13

決定日2016-01-13

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Substantially Equivalent

医療機器の概要

Sonishield 100 Antimicrobial Ultrasound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Quotient Medical. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K151070. 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 Sonishield 100 Antimicrobial Ultrasound Gel?

Sonishield 100 Antimicrobial Ultrasound Gel is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Quotient Medical. The 510(k) number is K151070.

When did Sonishield 100 Antimicrobial Ultrasound Gel receive FDA 510(k) clearance?

Sonishield 100 Antimicrobial Ultrasound Gel received FDA 510(k) clearance on 2016-01-13, under 510(k) number K151070.

Who is the listed applicant for Sonishield 100 Antimicrobial Ultrasound Gel?

The FDA 510(k) record lists Quotient Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonishield 100 Antimicrobial Ultrasound Gel?

The FDA product code for Sonishield 100 Antimicrobial Ultrasound Gel is MUI.

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ソニシールド100 抗菌超音波ジェル

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：MUI）

公式ソース