FDA 510(k)

Impla-NX（型號：ISE-270M）

K 號：K201192 · 2021-05-21

決定日期2021-05-21

產品代碼EBW

諮詢委員會DE

決定相當於

器材摘要

Impla-NX (Model: ISE-270M) is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2021-05-21 under 510(k) number K201192. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Impla-NX (Model: ISE-270M)?

Impla-NX (Model: ISE-270M) is a medical device that received FDA 510(k) clearance on 2021-05-21. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K201192.

When did Impla-NX (Model: ISE-270M) receive FDA 510(k) clearance?

Impla-NX (Model: ISE-270M) received FDA 510(k) clearance on 2021-05-21, under 510(k) number K201192.

Who is the listed applicant for Impla-NX (Model: ISE-270M)?

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

What is the FDA product code for Impla-NX (Model: ISE-270M)?

The FDA product code for Impla-NX (Model: ISE-270M) is EBW.

其他以 Micro-Nx 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：EBW）

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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