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FDA 510(k)

高速空氣涡轮手柄（G100、G200、G300、G400、G450、G500、G600、G700、G700L、G800、G800L）

K 號：K233122 · 2024-04-30

申請人Litu Tech , Ltd.
決定日期2024-04-30
產品代碼EFB
諮詢委員會DE
決定相當於

器材摘要

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) is the device name listed in this FDA 510(k) record. The listed applicant is Litu Tech , Ltd.. It received FDA 510(k) clearance on 2024-04-30 under 510(k) number K233122. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)?

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) is a medical device that received FDA 510(k) clearance on 2024-04-30. The listed applicant is Litu Tech , Ltd.. The 510(k) number is K233122.

When did High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) receive FDA 510(k) clearance?

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) received FDA 510(k) clearance on 2024-04-30, under 510(k) number K233122.

Who is the listed applicant for High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)?

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

What is the FDA product code for High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)?

The FDA product code for High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) is EFB.

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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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