FDA 510(k)

濃度；Denza；DENSITY Noir

K 號：K250065 · 2025-07-08

決定日期2025-07-08

產品代碼GEI

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

DENSITY; DENZA; DENSITY Noir is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical Incorporated. It received FDA 510(k) clearance on 2025-07-08 under 510(k) number K250065. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DENSITY; DENZA; DENSITY Noir?

DENSITY; DENZA; DENSITY Noir is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is Jeisys Medical Incorporated. The 510(k) number is K250065.

When did DENSITY; DENZA; DENSITY Noir receive FDA 510(k) clearance?

DENSITY; DENZA; DENSITY Noir received FDA 510(k) clearance on 2025-07-08, under 510(k) number K250065.

Who is the listed applicant for DENSITY; DENZA; DENSITY Noir?

FDA 510(k) 記錄將 Jeisys Medical Incorporated 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for DENSITY; DENZA; DENSITY Noir?

The FDA product code for DENSITY; DENZA; DENSITY Noir is GEI.

其他以 Jeisys Medical Incorporated 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：GEI）

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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