FDA 510(k)

NaviSuite SSI 版本

K 號：K163119 · 2017-05-01

決定日期2017-05-01

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

NaviSuite SSI Edition is the device name listed in this FDA 510(k) record. The listed applicant is Medcom GmbH. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K163119. 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 NaviSuite SSI Edition?

NaviSuite SSI Edition is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Medcom GmbH. The 510(k) number is K163119.

When did NaviSuite SSI Edition receive FDA 510(k) clearance?

NaviSuite SSI Edition received FDA 510(k) clearance on 2017-05-01, under 510(k) number K163119.

Who is the listed applicant for NaviSuite SSI Edition?

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

What is the FDA product code for NaviSuite SSI Edition?

The FDA product code for NaviSuite SSI Edition is LLZ.

其他以 Medcom 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：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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