FDA 510(k)

Dynamis Pro Family

K号: K213267 · 2022-09-08

决定日期2022-09-08

产品代码GEX

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决定实质等同

器械摘要

Dynamis Pro Family is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K213267. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

什么是Dynamis Pro系列？

Dynamis Pro Family is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Fotona D.O.O.. The 510(k) number is K213267.

Dynamis Pro Family何时获得FDA 510(k)批准？

Dynamis Pro Family received FDA 510(k) clearance on 2022-09-08, under 510(k) number K213267.

Dynamis Pro Family的申请人名单是谁？

FDA 510(k)记录显示Fotona D.O.O.为申请人。这本身并不能确立该设备制造商的身份。

Dynamis Pro Family的FDA产品代码是什么？

Dynamis Pro Family的FDA产品代码为GEX。这属于消化内科类别。

列明Fotona D.O.O.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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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。