FDA 510(k)

MESHEET 注意：此文本中未提供具体的医疗设备名称或相关监管文本，因此无法进行翻译。请提供具体的文本内容以便进行翻译。

K 號：K233544 · 2024-02-22

決定日期2024-02-22

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

MESHEET is the device name listed in this FDA 510(k) record. The listed applicant is Dentis Co., Ltd.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K233544. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MESHEET?

MESHEET is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K233544.

When did MESHEET receive FDA 510(k) clearance?

MESHEET received FDA 510(k) clearance on 2024-02-22, under 510(k) number K233544.

Who is the listed applicant for MESHEET?

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

What is the FDA product code for MESHEET?

The FDA product code for MESHEET is NXC.

其他以 Dentis Co., Ltd. 為申請人之記錄

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相關器械（代碼：NXC）

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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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。