FDA 510(k)

SnapshotGLO (KB100)

K 號：K242669 · 2025-03-26

決定日期2025-03-26

產品代碼QJF

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

SnapshotGLO (KB100) 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 2025-03-26 under 510(k) number K242669. The device is classified under product code QJF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SnapshotGLO (KB100)?

SnapshotGLO (KB100) is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Kent Imaging, Inc.. The 510(k) number is K242669.

When did SnapshotGLO (KB100) receive FDA 510(k) clearance?

SnapshotGLO (KB100) received FDA 510(k) clearance on 2025-03-26, under 510(k) number K242669.

Who is the listed applicant for SnapshotGLO (KB100)?

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 SnapshotGLO (KB100)?

The FDA product code for SnapshotGLO (KB100) is QJF.

其他以 Kent Imaging, Inc. 為申請人之記錄

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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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