FDA 510(k)

E-Guard

K 號：K201173 · 2020-11-27

決定日期2020-11-27

產品代碼MQC

決定相當於

器材摘要

E-Guard is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2020-11-27 under 510(k) number K201173. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the E-Guard?

E-Guard is a medical device that received FDA 510(k) clearance on 2020-11-27. The listed applicant is Envisiontec GmbH. The 510(k) number is K201173.

When did E-Guard receive FDA 510(k) clearance?

E-Guard received FDA 510(k) clearance on 2020-11-27, under 510(k) number K201173.

Who is the listed applicant for E-Guard?

The FDA 510(k) record lists Envisiontec GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Guard?

The FDA product code for E-Guard is MQC.

其他以 Envisiontec GmbH 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：MQC）

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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