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FDA 510(k)

強化版 AURORA™ 医療二極體系及其相關配件

K 號：K230076 · 2023-03-08

申請人Psoria-Shield, Inc.
決定日期2023-03-08
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

Enhanced AURORA™ Medical Diode System, and related accessories is the device name listed in this FDA 510(k) record. The listed applicant is Psoria-Shield, Inc.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K230076. 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 Enhanced AURORA™ Medical Diode System, and related accessories?

Enhanced AURORA™ Medical Diode System, and related accessories is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Psoria-Shield, Inc.. The 510(k) number is K230076.

When did Enhanced AURORA™ Medical Diode System, and related accessories receive FDA 510(k) clearance?

Enhanced AURORA™ Medical Diode System, and related accessories received FDA 510(k) clearance on 2023-03-08, under 510(k) number K230076.

Who is the listed applicant for Enhanced AURORA™ Medical Diode System, and related accessories?

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

What is the FDA product code for Enhanced AURORA™ Medical Diode System, and related accessories?

The FDA product code for Enhanced AURORA™ Medical Diode System, and related accessories is FTC.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K254234光療系統（DUV-COMBO）Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425紫外光療法設備APK Technology Co., Ltd.K244022308nm 紫外光光療系統 (UV-K)；308nm 紫外光光療系統 (UV-X)；308nm 紫外光光療系統 (UV-Y)；308nm 紫外光光療系統 (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer光療設備（CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K）Xuzhou Kernel Medical Equipment Co., Ltd.K242908紫外光療法設備（分組A：SQ308PCHFD、SQ308PCQFD、SQ308PCPFD、SQ308PCNFD、SQ308PCMFD）；紫外光療法設備（分組B：SQ308PHTFF、SQ308PHSFF、SQ308PHRFF、SQ308PHZFG、SQ308PPUFF、SQ308PPVFF、SQ308PPWFG）Shanghai Sigma High-Tech Co., Ltd.

官方來源

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