FDA 510(k)

Dolphin/IQ、Dolphin/4D 及 Dolphin/MAX 配備 Dolphin/XF 机器人配件

K 號：K202742 · 2021-01-25

決定日期2021-01-25

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory is the device name listed in this FDA 510(k) record. The listed applicant is Viasonix , Ltd.. It received FDA 510(k) clearance on 2021-01-25 under 510(k) number K202742. 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, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory?

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory is a medical device that received FDA 510(k) clearance on 2021-01-25. The listed applicant is Viasonix , Ltd.. The 510(k) number is K202742.

When did Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory receive FDA 510(k) clearance?

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory received FDA 510(k) clearance on 2021-01-25, under 510(k) number K202742.

Who is the listed applicant for Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory?

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, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory?

The FDA product code for Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory 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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