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FDA 510(k)

視點6

K 號:K173456 · 2018-01-05

決定日期2018-01-05
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

ViewPoint 6 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K173456. 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 ViewPoint 6?

ViewPoint 6 is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Ge Medical Systems Ultrasound and Primary. The 510(k) number is K173456.

When did ViewPoint 6 receive FDA 510(k) clearance?

ViewPoint 6 received FDA 510(k) clearance on 2018-01-05, under 510(k) number K173456.

Who is the listed applicant for ViewPoint 6?

The FDA 510(k) record lists Ge Medical Systems Ultrasound and Primary as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViewPoint 6?

The FDA product code for ViewPoint 6 is LLZ.

相關臨床試驗

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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。

官方來源

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