FDA 510(k)

iSR'obot活检套装

K号: K163502 · 2017-05-16

决定日期2017-05-16

产品代码ITX

咨询委员会RA

决定实质等同

器械摘要

iSR'obot Biopsy Kit is the device name listed in this FDA 510(k) record. The listed applicant is Biobot Surgical Pte., Ltd.. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K163502. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iSR'obot Biopsy Kit?

iSR'obot Biopsy Kit is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Biobot Surgical Pte., Ltd.. The 510(k) number is K163502.

When did iSR'obot Biopsy Kit receive FDA 510(k) clearance?

iSR'obot Biopsy Kit received FDA 510(k) clearance on 2017-05-16, under 510(k) number K163502.

Who is the listed applicant for iSR'obot Biopsy Kit?

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

What is the FDA product code for iSR'obot Biopsy Kit?

The FDA product code for iSR'obot Biopsy Kit is ITX.

列明Biobot Surgical Pte., 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。

K232320iSR`obot 莫娜丽莎 2.0 K213411iSR’obot 莫娜丽莎 2.0 K203659iSR'obot 莫娜丽莎 1.0 K161109iSR'obot MRI-US 融合

官方来源

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