FDA 510(k)

Aquilion Lightning, TSX-036A/1, V8.4

K 號：K170019 · 2017-02-02

決定日期2017-02-02

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Aquilion Lightning, TSX-036A/1, V8.4 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-02-02 under 510(k) number K170019. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aquilion Lightning, TSX-036A/1, V8.4?

Aquilion Lightning, TSX-036A/1, V8.4 is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170019.

When did Aquilion Lightning, TSX-036A/1, V8.4 receive FDA 510(k) clearance?

Aquilion Lightning, TSX-036A/1, V8.4 received FDA 510(k) clearance on 2017-02-02, under 510(k) number K170019.

Who is the listed applicant for Aquilion Lightning, TSX-036A/1, V8.4?

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

What is the FDA product code for Aquilion Lightning, TSX-036A/1, V8.4?

The FDA product code for Aquilion Lightning, TSX-036A/1, V8.4 is JAK.

其他以 Toshibamedical Systems Corporation 為申請人之記錄

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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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