FDA 510(k)

健康FLD

K 號：K233080 · 2024-02-08

決定日期2024-02-08

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

HealthFLD is the device name listed in this FDA 510(k) record. The listed applicant is Nano-X AI , Ltd.. It received FDA 510(k) clearance on 2024-02-08 under 510(k) number K233080. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HealthFLD?

HealthFLD is a medical device that received FDA 510(k) clearance on 2024-02-08. The listed applicant is Nano-X AI , Ltd.. The 510(k) number is K233080.

When did HealthFLD receive FDA 510(k) clearance?

HealthFLD received FDA 510(k) clearance on 2024-02-08, under 510(k) number K233080.

Who is the listed applicant for HealthFLD?

The FDA 510(k) record lists Nano-X AI , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HealthFLD?

The FDA product code for HealthFLD is JAK.

其他以 Nano-X AI , Ltd. 為申請人之記錄

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K241440健康CCSng

相關器械（代碼：JAK）

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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