FDA 510(k)

AXIR-CX

K 號：K213520 · 2022-08-19

決定日期2022-08-19

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

AXIR-CX is the device name listed in this FDA 510(k) record. The listed applicant is Radisen Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K213520. 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 AXIR-CX?

AXIR-CX is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Radisen Co., Ltd.. The 510(k) number is K213520.

When did AXIR-CX receive FDA 510(k) clearance?

AXIR-CX received FDA 510(k) clearance on 2022-08-19, under 510(k) number K213520.

Who is the listed applicant for AXIR-CX?

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

What is the FDA product code for AXIR-CX?

The FDA product code for AXIR-CX is LLZ.

其他以 Radisen Co., Ltd. 為申請人之記錄

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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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