FDA 510(k)

一次性內支氣管阻斷管

K 號：K232580 · 2023-12-14

申請人Shenzhen Insighters Medical Technology Co., Ltd.

決定日期2023-12-14

產品代碼CBI

諮詢委員會AN

決定相當於

器材摘要

Disposable Endobronchial Blocker Tube is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Insighters Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K232580. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Endobronchial Blocker Tube?

Disposable Endobronchial Blocker Tube is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Shenzhen Insighters Medical Technology Co., Ltd.. The 510(k) number is K232580.

When did Disposable Endobronchial Blocker Tube receive FDA 510(k) clearance?

Disposable Endobronchial Blocker Tube received FDA 510(k) clearance on 2023-12-14, under 510(k) number K232580.

Who is the listed applicant for Disposable Endobronchial Blocker Tube?

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

What is the FDA product code for Disposable Endobronchial Blocker Tube?

The FDA product code for Disposable Endobronchial Blocker Tube is CBI.

其他以 Shenzhen Insighters Medical Technology Co., Ltd. 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。

K242793Insighters™ 單次使用支氣管鏡/Insight Bimodel-Integral iS-B12A 4.6/2.0；Insighters™ 單次使用支氣管鏡/Insight Bimodel-Integral iS-B22A 5.5 /2.6；Insighters™ 單次使用支氣管鏡/Insight Bimodel-Integral iS-B26A 6.0/3.0；Insighters™ Insight Workstation iS-PF1。K232529一次性雙腔內支氣管管

相關器械（代碼：CBI）

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。

官方來源

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