FDA 510(k)

显微镜除雾系统

K号: K182080 · 2018-09-19

决定日期2018-09-19

产品代码GCJ

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决定实质等同

器械摘要

Scope Antifogging System is the device name listed in this FDA 510(k) record. The listed applicant is Xodus Medical, Inc.. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K182080. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Scope Antifogging System?

Scope Antifogging System is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Xodus Medical, Inc.. The 510(k) number is K182080.

When did Scope Antifogging System receive FDA 510(k) clearance?

Scope Antifogging System received FDA 510(k) clearance on 2018-09-19, under 510(k) number K182080.

Who is the listed applicant for Scope Antifogging System?

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

What is the FDA product code for Scope Antifogging System?

The FDA product code for Scope Antifogging System is GCJ.

列明Xodus Medical, 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。

K260903Hot Pink Pad Warming System

相关器械（代码：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

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