FDA 510(k)

海豚/IQ 和海豚/4D

K 號：K170859 · 2017-11-14

決定日期2017-11-14

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Dolphin/IQ and Dolphin/4D is the device name listed in this FDA 510(k) record. The listed applicant is Viasonix , Ltd.. It received FDA 510(k) clearance on 2017-11-14 under 510(k) number K170859. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dolphin/IQ and Dolphin/4D?

Dolphin/IQ and Dolphin/4D is a medical device that received FDA 510(k) clearance on 2017-11-14. The listed applicant is Viasonix , Ltd.. The 510(k) number is K170859.

When did Dolphin/IQ and Dolphin/4D receive FDA 510(k) clearance?

Dolphin/IQ and Dolphin/4D received FDA 510(k) clearance on 2017-11-14, under 510(k) number K170859.

Who is the listed applicant for Dolphin/IQ and Dolphin/4D?

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

What is the FDA product code for Dolphin/IQ and Dolphin/4D?

The FDA product code for Dolphin/IQ and Dolphin/4D is IYN.

其他以 Viasonix , Ltd. 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：IYN）

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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