FDA 510(k)

イルカ/IQ、イルカ/4Dおよびイルカ/MAX、イルカ/XFロボットアテンシブアクセサリー付き

K番号: K202742 · 2021-01-25

決定日2021-01-25

製品コードIYN

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてViasonix , Ltd.を記載するその他の記録

K242662ファルコン/Xプレス（ファルコン/Xプレス）K192607ライトウォーク K191023イルカ/IQ、イルカ/4Dおよびイルカ/MAX K170859イルカ/IQおよびイルカ/4D

公式ソース

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