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FDA 510(k)

Girgis Scope Video 200雙刀喉鏡（GSV200.DBL）

K 號：K163412 · 2017-06-22

申請人Girgis Scope, LLC
決定日期2017-06-22
產品代碼CCW
諮詢委員會AN
決定相當於

器材摘要

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is the device name listed in this FDA 510(k) record. The listed applicant is Girgis Scope, LLC. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K163412. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)?

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Girgis Scope, LLC. The 510(k) number is K163412.

When did Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) receive FDA 510(k) clearance?

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) received FDA 510(k) clearance on 2017-06-22, under 510(k) number K163412.

Who is the listed applicant for Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)?

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

What is the FDA product code for Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)?

The FDA product code for Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is CCW.

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：CCW）

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。

K191602APA 氧氣刀Venner Medical (Singapore) Pte, Ltd.

官方來源

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