FDA 510(k)

APA 氧氣刀

K 號：K191602 · 2019-08-02

決定日期2019-08-02

產品代碼CCW

諮詢委員會AN

決定相當於

器材摘要

APA Oxy Blade is the device name listed in this FDA 510(k) record. The listed applicant is Venner Medical (Singapore) Pte, Ltd.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K191602. 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 APA Oxy Blade?

APA Oxy Blade is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Venner Medical (Singapore) Pte, Ltd.. The 510(k) number is K191602.

When did APA Oxy Blade receive FDA 510(k) clearance?

APA Oxy Blade received FDA 510(k) clearance on 2019-08-02, under 510(k) number K191602.

Who is the listed applicant for APA Oxy Blade?

The FDA 510(k) record lists Venner Medical (Singapore) Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APA Oxy Blade?

The FDA product code for APA Oxy Blade is CCW.

其他以 Venner Medical (Singapore) Pte, 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。

K192511Venner PneuX™ TT（氣管切開管）尺寸 7.0 mm，Venner PneuX™ TT（氣管切開管）尺寸 8.0 mm，Venner PneuX™ TT（氣管切開管）尺寸 9.0 mm K192120Venner PneuX™ ETT（氣管內管）6 mm，Venner PneuX™ ETT（氣管內管）7 mm，Venner PneuX™ ETT（氣管內管）8 mm，Venner PneuX™ ETT（氣管內管）9 mm

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。

K163412Girgis Scope Video 200雙刀喉鏡（GSV200.DBL）Girgis Scope, LLC

官方來源

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