FDA 510(k)

LiNA OperaScope带HDMI线和机载LCD - 6台，LiNA OperaScope录制模块

K号: K193007 · 2020-01-17

决定日期2020-01-17

产品代码HIH

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决定实质等同

器械摘要

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K193007. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module?

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Lina Medical Aps. The 510(k) number is K193007.

When did LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module receive FDA 510(k) clearance?

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module received FDA 510(k) clearance on 2020-01-17, under 510(k) number K193007.

Who is the listed applicant for LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module?

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

What is the FDA product code for LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module?

The FDA product code for LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module is HIH.

列明Lina Medical Aps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。

K240227LiNA CystoVu® HD (CYV-100-5; CYV-101-5); LiNA ScopeVu® (SCP-100-1)K223932SafeAir combi（SFR-combi-US）K221085LiNA OperaScope 针 K182224SafeAir烟雾抽吸器紧凑型 K182354SafeAir伸缩烟雾笔 K171113LiNA OperaScope带HDMI线和机载LCD-单台，LiNA OperaScope带HDMI线和机载LCD-6台，LiNA OperaScope录制模块

查看所有 7 个设备 →

相关器械（代码：HIH）

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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