FDA 510(k)

Dolphin/IQ, Dolphin/4D 和 Dolphin/MAX

K号: K191023 · 2019-05-16

决定日期2019-05-16

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Dolphin/IQ, Dolphin/4D and Dolphin/MAX is the device name listed in this FDA 510(k) record. The listed applicant is Viasonix , Ltd.. It received FDA 510(k) clearance on 2019-05-16 under 510(k) number K191023. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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

Dolphin/IQ, Dolphin/4D and Dolphin/MAX is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is Viasonix , Ltd.. The 510(k) number is K191023.

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

Dolphin/IQ, Dolphin/4D and Dolphin/MAX received FDA 510(k) clearance on 2019-05-16, under 510(k) number K191023.

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

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?

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

列明Viasonix , Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242662Falcon/Xpress (Falcon/Xpress)K202742Dolphin/IQ, Dolphin/4D 和 Dolphin/MAX 配备 Dolphin/XF 机器人附件 K192607LiteWalk K170859Dolphin/IQ 和 Dolphin/4D

相关器械（代码：IYN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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