FDA 510(k)

EzDent-i / E2 / Prora View / Smart M 觀察器 (v3.5)

K 號：K241114 · 2024-07-23

決定日期2024-07-23

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) is the device name listed in this FDA 510(k) record. The listed applicant is Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2024-07-23 under 510(k) number K241114. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)?

EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) is a medical device that received FDA 510(k) clearance on 2024-07-23. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K241114.

When did EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) receive FDA 510(k) clearance?

EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) received FDA 510(k) clearance on 2024-07-23, under 510(k) number K241114.

Who is the listed applicant for EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)?

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

What is the FDA product code for EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)?

The FDA product code for EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) is LLZ.

其他以 Ewoosoft 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：LLZ）

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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