FDA 510(k)

VivaSight-DL 系统

K号: K181886 · 2018-11-14

决定日期2018-11-14

产品代码CBI

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决定实质等同

器械摘要

VivaSight-DL System is the device name listed in this FDA 510(k) record. The listed applicant is Etview , Ltd.. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K181886. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VivaSight-DL System?

VivaSight-DL System is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Etview , Ltd.. The 510(k) number is K181886.

When did VivaSight-DL System receive FDA 510(k) clearance?

VivaSight-DL System received FDA 510(k) clearance on 2018-11-14, under 510(k) number K181886.

Who is the listed applicant for VivaSight-DL System?

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

What is the FDA product code for VivaSight-DL System?

The FDA product code for VivaSight-DL System is CBI.

列明Etview , Ltd.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。

K181880VivaSight-SL（电视转播）系统 K152438ETView VivaSight-SL（TVT）系统

相关器械（代码：CBI）

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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