FDA 510(k)

OWL 隔离套管

K号: K170708 · 2017-06-27

决定日期2017-06-27

产品代码GXI

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决定实质等同

器械摘要

OWL RF INSULATED CANNULAE is the device name listed in this FDA 510(k) record. The listed applicant is Diros Technology, Inc.. It received FDA 510(k) clearance on 2017-06-27 under 510(k) number K170708. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OWL RF INSULATED CANNULAE?

OWL RF INSULATED CANNULAE is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is Diros Technology, Inc.. The 510(k) number is K170708.

When did OWL RF INSULATED CANNULAE receive FDA 510(k) clearance?

OWL RF INSULATED CANNULAE received FDA 510(k) clearance on 2017-06-27, under 510(k) number K170708.

Who is the listed applicant for OWL RF INSULATED CANNULAE?

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

What is the FDA product code for OWL RF INSULATED CANNULAE?

The FDA product code for OWL RF INSULATED CANNULAE is GXI.

相关器械（代码：GXI）

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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器械摘要

常见问题

相关临床试验

相关器械（代码：GXI）

官方来源