FDA 510(k)

牙科手持機（型號：J6-126、J6-136、SH11W2、SH11W3、W401LW、W15LW、W142LW、W11L）

K 號：K240337 · 2024-11-13

申請人Guangdong Jinme Medical Technology Co., Ltd.

決定日期2024-11-13

產品代碼EFB

諮詢委員會DE

決定相當於

器材摘要

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-13 under 510(k) number K240337. 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 Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) is a medical device that received FDA 510(k) clearance on 2024-11-13. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. The 510(k) number is K240337.

When did Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) receive FDA 510(k) clearance?

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) received FDA 510(k) clearance on 2024-11-13, under 510(k) number K240337.

Who is the listed applicant for Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

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

What is the FDA product code for Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

The FDA product code for Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) is EFB.

其他以 Guangdong Jinme 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。

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相關器械（代碼：EFB）

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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官方來源

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