FDA 510(k)

快照NIR型 KD205

K 號：K240601 · 2024-04-02

決定日期2024-04-02

產品代碼MUD

諮詢委員會履歷

決定相當於

器材摘要

SnapshotNIR model KD205 is the device name listed in this FDA 510(k) record. The listed applicant is Kent Imaging, Inc.. It received FDA 510(k) clearance on 2024-04-02 under 510(k) number K240601. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SnapshotNIR model KD205?

SnapshotNIR model KD205 is a medical device that received FDA 510(k) clearance on 2024-04-02. The listed applicant is Kent Imaging, Inc.. The 510(k) number is K240601.

When did SnapshotNIR model KD205 receive FDA 510(k) clearance?

SnapshotNIR model KD205 received FDA 510(k) clearance on 2024-04-02, under 510(k) number K240601.

Who is the listed applicant for SnapshotNIR model KD205?

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

What is the FDA product code for SnapshotNIR model KD205?

The FDA product code for SnapshotNIR model KD205 is MUD.

其他以 Kent Imaging, 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：MUD）

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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