FDA 510(k)

Ilumien Optis、Optis 集成、Optis 行動版

K 號：K183320 · 2019-04-02

申請人St. Jude Medical (Now Abbott Medical)

決定日期2019-04-02

產品代碼NQQ

諮詢委員會RA

決定相當於

器材摘要

Ilumien Optis, Optis Integrated, Optis Mobile is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical (Now Abbott Medical). It received FDA 510(k) clearance on 2019-04-02 under 510(k) number K183320. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ilumien Optis, Optis Integrated, Optis Mobile?

Ilumien Optis, Optis Integrated, Optis Mobile is a medical device that received FDA 510(k) clearance on 2019-04-02. The listed applicant is St. Jude Medical (Now Abbott Medical). The 510(k) number is K183320.

When did Ilumien Optis, Optis Integrated, Optis Mobile receive FDA 510(k) clearance?

Ilumien Optis, Optis Integrated, Optis Mobile received FDA 510(k) clearance on 2019-04-02, under 510(k) number K183320.

Who is the listed applicant for Ilumien Optis, Optis Integrated, Optis Mobile?

The FDA 510(k) record lists St. Jude Medical (Now Abbott Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ilumien Optis, Optis Integrated, Optis Mobile?

The FDA product code for Ilumien Optis, Optis Integrated, Optis Mobile is NQQ.

其他以 St. Jude Medical (Now Abbott Medical) 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：NQQ）

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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