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FDA 510(k)

TruView 光纖纜，TruView 横向拉開器光纖纜，分叉光纖纜配通用端子

K 號：K200874 · 2020-06-30

申請人Innovasis, Inc.
決定日期2020-06-30
產品代碼FST
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

TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2020-06-30 under 510(k) number K200874. The device is classified under product code FST. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End?

TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End is a medical device that received FDA 510(k) clearance on 2020-06-30. The listed applicant is Innovasis, Inc.. The 510(k) number is K200874.

When did TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End receive FDA 510(k) clearance?

TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End received FDA 510(k) clearance on 2020-06-30, under 510(k) number K200874.

Who is the listed applicant for TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End?

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

What is the FDA product code for TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End?

The FDA product code for TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End is FST.

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

其他以 Innovasis, Inc. 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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