FDA 510(k)

MREplus+ 軟體

K 號：K183193 · 2019-08-01

決定日期2019-08-01

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

MREplus+ Software is the device name listed in this FDA 510(k) record. The listed applicant is Resoundant, Inc.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) number K183193. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MREplus+ Software?

MREplus+ Software is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is Resoundant, Inc.. The 510(k) number is K183193.

When did MREplus+ Software receive FDA 510(k) clearance?

MREplus+ Software received FDA 510(k) clearance on 2019-08-01, under 510(k) number K183193.

Who is the listed applicant for MREplus+ Software?

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

What is the FDA product code for MREplus+ Software?

The FDA product code for MREplus+ Software is LLZ.

其他以 Resoundant, Inc. 為申請人之記錄

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K201389Resoundant 選聲驅動系統

相關器械（代碼：LLZ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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