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FDA 510(k)

Hidroxa SE30

K 號：K241267 · 2024-10-17

申請人Hidroxa Medical AB
決定日期2024-10-17
產品代碼EGJ
諮詢委員會PM
決定相當於

器材摘要

Hidroxa SE30 is the device name listed in this FDA 510(k) record. The listed applicant is Hidroxa Medical AB. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K241267. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hidroxa SE30?

Hidroxa SE30 is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Hidroxa Medical AB. The 510(k) number is K241267.

When did Hidroxa SE30 receive FDA 510(k) clearance?

Hidroxa SE30 received FDA 510(k) clearance on 2024-10-17, under 510(k) number K241267.

Who is the listed applicant for Hidroxa SE30?

The FDA 510(k) record lists Hidroxa Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hidroxa SE30?

The FDA product code for Hidroxa SE30 is EGJ.

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：EGJ）

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。

K242041STOPWET離子電泳儀（SW01）Taiwan Medical Electronics Co., Ltd.K232020離子導入電極Top-Rank Health Care Co., Ltd.K192749皮麗乾Dermadry Laboratories, Inc.K191436薩利歐Saalmann Medical GmbH & Co. KGK170835電子止汗器，敏感型電子止汗器，精英型電子止汗器Hightech DevelopmentK170291離子電療設備Soterix Medical, Inc.

官方來源

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