FDA 510(k)

麗比回聲：優先

K 號：K220956 · 2022-07-20

決定日期2022-07-20

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Libby Echo:Prio is the device name listed in this FDA 510(k) record. The listed applicant is Dyad Medical, Inc.. It received FDA 510(k) clearance on 2022-07-20 under 510(k) number K220956. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Libby Echo:Prio?

Libby Echo:Prio is a medical device that received FDA 510(k) clearance on 2022-07-20. The listed applicant is Dyad Medical, Inc.. The 510(k) number is K220956.

When did Libby Echo:Prio receive FDA 510(k) clearance?

Libby Echo:Prio received FDA 510(k) clearance on 2022-07-20, under 510(k) number K220956.

Who is the listed applicant for Libby Echo:Prio?

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

What is the FDA product code for Libby Echo:Prio?

The FDA product code for Libby Echo:Prio is QIH.

其他以 Dyad Medical, Inc. 為申請人之記錄

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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相關器械（代碼：QIH）

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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