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FDA 510(k)

图尔特仪器舱

K号: K200240 · 2020-04-30

决定日期2020-04-30
产品代码FRG
咨询委员会医疗设备监管文本翻译如下: HO 请注意,由于您没有提供具体的医疗设备监管文本内容,以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

Turbett Instrument Pod is the device name listed in this FDA 510(k) record. The listed applicant is Turbett Surgical, Inc.. It received FDA 510(k) clearance on 2020-04-30 under 510(k) number K200240. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Turbett Instrument Pod?

Turbett Instrument Pod is a medical device that received FDA 510(k) clearance on 2020-04-30. The listed applicant is Turbett Surgical, Inc.. The 510(k) number is K200240.

When did Turbett Instrument Pod receive FDA 510(k) clearance?

Turbett Instrument Pod received FDA 510(k) clearance on 2020-04-30, under 510(k) number K200240.

Who is the listed applicant for Turbett Instrument Pod?

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

What is the FDA product code for Turbett Instrument Pod?

The FDA product code for Turbett Instrument Pod is FRG.

相关临床试验

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。

列明Turbett Surgical, Inc.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。

相关器械(代码:FRG)

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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数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

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