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FDA 510(k)

Rextar Pro

K 號：K242185 · 2024-12-04

申請人Raypia Co., Ltd.
決定日期2024-12-04
產品代碼EHD
諮詢委員會DE
決定相當於

器材摘要

Rextar Pro is the device name listed in this FDA 510(k) record. The listed applicant is Raypia Co., Ltd.. It received FDA 510(k) clearance on 2024-12-04 under 510(k) number K242185. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rextar Pro?

Rextar Pro is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Raypia Co., Ltd.. The 510(k) number is K242185.

When did Rextar Pro receive FDA 510(k) clearance?

Rextar Pro received FDA 510(k) clearance on 2024-12-04, under 510(k) number K242185.

Who is the listed applicant for Rextar Pro?

The FDA 510(k) record lists Raypia Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rextar Pro?

The FDA product code for Rextar Pro is EHD.

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：EHD）

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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