FDA 510(k)

影響與X-Ranger

K 號：K210479 · 2021-03-19

決定日期2021-03-19

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

IMPACT and X-Ranger is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2021-03-19 under 510(k) number K210479. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IMPACT and X-Ranger?

IMPACT and X-Ranger is a medical device that received FDA 510(k) clearance on 2021-03-19. The listed applicant is Minxray, Inc.. The 510(k) number is K210479.

When did IMPACT and X-Ranger receive FDA 510(k) clearance?

IMPACT and X-Ranger received FDA 510(k) clearance on 2021-03-19, under 510(k) number K210479.

Who is the listed applicant for IMPACT and X-Ranger?

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

What is the FDA product code for IMPACT and X-Ranger?

The FDA product code for IMPACT and X-Ranger is IZL.

其他以 Minxray, 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：IZL）

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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