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FDA 510(k)

Tellos ISQ Buddy

K 號：K143445 · 2016-01-07

申請人Tellos Medical AB
決定日期2016-01-07
產品代碼EKX
諮詢委員會DE
決定相當於

器材摘要

Tellos ISQ Buddy is the device name listed in this FDA 510(k) record. The listed applicant is Tellos Medical AB. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K143445. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tellos ISQ Buddy?

Tellos ISQ Buddy is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Tellos Medical AB. The 510(k) number is K143445.

When did Tellos ISQ Buddy receive FDA 510(k) clearance?

Tellos ISQ Buddy received FDA 510(k) clearance on 2016-01-07, under 510(k) number K143445.

Who is the listed applicant for Tellos ISQ Buddy?

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

What is the FDA product code for Tellos ISQ Buddy?

The FDA product code for Tellos ISQ Buddy is EKX.

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：EKX）

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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