FDA 510(k)

308nm Excimer光療設備（CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K）

K 號：K242977 · 2025-02-06

申請人Xuzhou Kernel Medical Equipment Co., Ltd.

決定日期2025-02-06

產品代碼FTC

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

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K242977. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)?

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K242977.

When did 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) receive FDA 510(k) clearance?

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) received FDA 510(k) clearance on 2025-02-06, under 510(k) number K242977.

Who is the listed applicant for 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)?

FDA 510(k) 記錄將徐州核子醫療設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)?

The FDA product code for 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) is FTC.

其他以 Xuzhou Kernel Medical Equipment Co., 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：FTC）

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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