FDA 510(k)

XD設備名稱醫療設備規範文本注意事項：以下為翻譯版本，原文中的公司名稱、產品名稱、FDA、510(k)、PMA、NCT、PMID、識別碼和網址等均未進行翻譯。 --- XD設備名稱 FDA許可 510(k)申請 PMA申請 NCT實驗編號 PMID文獻編號識別碼網址

K 號：K220779 · 2022-04-15

決定日期2022-04-15

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

XD is the device name listed in this FDA 510(k) record. The listed applicant is Mirada Medical, Ltd.. It received FDA 510(k) clearance on 2022-04-15 under 510(k) number K220779. 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 XD?

XD is a medical device that received FDA 510(k) clearance on 2022-04-15. The listed applicant is Mirada Medical, Ltd.. The 510(k) number is K220779.

When did XD receive FDA 510(k) clearance?

XD received FDA 510(k) clearance on 2022-04-15, under 510(k) number K220779.

Who is the listed applicant for XD?

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

What is the FDA product code for XD?

The FDA product code for XD is LLZ.

其他以 Mirada Medical, Ltd. 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：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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