FDA 510(k)

下一代 iBOT

K号: K172601 · 2018-03-02

决定日期2018-03-02

产品代码IMK

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决定实质等同

器械摘要

Next Generation iBOT is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research & Development Corp.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K172601. The device is classified under product code IMK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Next Generation iBOT?

Next Generation iBOT is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Deka Research & Development Corp.. The 510(k) number is K172601.

When did Next Generation iBOT receive FDA 510(k) clearance?

Next Generation iBOT received FDA 510(k) clearance on 2018-03-02, under 510(k) number K172601.

Who is the listed applicant for Next Generation iBOT?

The FDA 510(k) record lists Deka Research & Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Next Generation iBOT?

The FDA product code for Next Generation iBOT is IMK.

列明Deka Research & Development Corp.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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官方来源

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