FDA 510(k)

SURGIVISIO 设备

K号: K220946 · 2022-04-15

决定日期2022-04-15

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

SURGIVISIO Device is the device name listed in this FDA 510(k) record. The listed applicant is Ecential Robotics. It received FDA 510(k) clearance on 2022-04-15 under 510(k) number K220946. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SURGIVISIO Device?

SURGIVISIO Device is a medical device that received FDA 510(k) clearance on 2022-04-15. The listed applicant is Ecential Robotics. The 510(k) number is K220946.

When did SURGIVISIO Device receive FDA 510(k) clearance?

SURGIVISIO Device received FDA 510(k) clearance on 2022-04-15, under 510(k) number K220946.

Who is the listed applicant for SURGIVISIO Device?

FDA 510(k)记录中列出Ecential Robotics为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for SURGIVISIO Device?

The FDA product code for SURGIVISIO Device is OWB.

列明Ecential Robotics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。

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