FDA 510(k)

SpotLight/SpotLight Duo（含DLIR選項）

K 號：K230370 · 2023-10-13

決定日期2023-10-13

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

SpotLight/SpotLight Duo (with DLIR option) is the device name listed in this FDA 510(k) record. The listed applicant is Arineta , Ltd.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K230370. 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 SpotLight/SpotLight Duo (with DLIR option)?

SpotLight/SpotLight Duo (with DLIR option) is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Arineta , Ltd.. The 510(k) number is K230370.

When did SpotLight/SpotLight Duo (with DLIR option) receive FDA 510(k) clearance?

SpotLight/SpotLight Duo (with DLIR option) received FDA 510(k) clearance on 2023-10-13, under 510(k) number K230370.

Who is the listed applicant for SpotLight/SpotLight Duo (with DLIR option)?

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

What is the FDA product code for SpotLight/SpotLight Duo (with DLIR option)?

The FDA product code for SpotLight/SpotLight Duo (with DLIR option) is JAK.

其他以 Arineta , 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：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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