FDA 510(k)

Adora DRFi (04550010)

K 號：K242948 · 2024-12-23

決定日期2024-12-23

產品代碼JAA

諮詢委員會RA

決定相當於

器材摘要

Adora DRFi (04550010) is the device name listed in this FDA 510(k) record. The listed applicant is Nrt X-Ray A/S. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K242948. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Adora DRFi (04550010)?

Adora DRFi (04550010) is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Nrt X-Ray A/S. The 510(k) number is K242948.

When did Adora DRFi (04550010) receive FDA 510(k) clearance?

Adora DRFi (04550010) received FDA 510(k) clearance on 2024-12-23, under 510(k) number K242948.

Who is the listed applicant for Adora DRFi (04550010)?

The FDA 510(k) record lists Nrt X-Ray A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Adora DRFi (04550010)?

The FDA product code for Adora DRFi (04550010) is JAA.

其他以 Nrt X-Ray A/S 為申請人之記錄

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K173631Intelli-C

相關器械（代碼：JAA）

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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