FDA 510(k)

Libby IAAA v1.0

K 號：K210931 · 2021-12-17

決定日期2021-12-17

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Libby IAAA v1.0 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 2021-12-17 under 510(k) number K210931. 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 Libby IAAA v1.0?

Libby IAAA v1.0 is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Dyad Medical, Inc.. The 510(k) number is K210931.

When did Libby IAAA v1.0 receive FDA 510(k) clearance?

Libby IAAA v1.0 received FDA 510(k) clearance on 2021-12-17, under 510(k) number K210931.

Who is the listed applicant for Libby IAAA v1.0?

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 IAAA v1.0?

The FDA product code for Libby IAAA v1.0 is LLZ.

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。

K220956麗比回聲：優先

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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