FDA 510(k)

SUPRIA 配置導向選項

K 號：K161748 · 2016-08-17

申請人Hitachi Medical Systems America, Inc.

決定日期2016-08-17

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

SUPRIA w/guideShot Option is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K161748. 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 SUPRIA w/guideShot Option?

SUPRIA w/guideShot Option is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K161748.

When did SUPRIA w/guideShot Option receive FDA 510(k) clearance?

SUPRIA w/guideShot Option received FDA 510(k) clearance on 2016-08-17, under 510(k) number K161748.

Who is the listed applicant for SUPRIA w/guideShot Option?

The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPRIA w/guideShot Option?

The FDA product code for SUPRIA w/guideShot Option is JAK.

其他以 Hitachi Medical Systems America, Inc. 為申請人之記錄

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相關器械（代碼：JAK）

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