FDA 510(k)

iRAD

K 號：K212470 · 2021-10-20

決定日期2021-10-20

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

iRAD is the device name listed in this FDA 510(k) record. The listed applicant is Claritas Healthtech Pte, Ltd.. It received FDA 510(k) clearance on 2021-10-20 under 510(k) number K212470. 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 iRAD?

iRAD is a medical device that received FDA 510(k) clearance on 2021-10-20. The listed applicant is Claritas Healthtech Pte, Ltd.. The 510(k) number is K212470.

When did iRAD receive FDA 510(k) clearance?

iRAD received FDA 510(k) clearance on 2021-10-20, under 510(k) number K212470.

Who is the listed applicant for iRAD?

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

What is the FDA product code for iRAD?

The FDA product code for iRAD is LLZ.

其他以 Claritas Healthtech Pte, 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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