FDA 510(k)

凝胶-e Flex+凝胶OTC

K号: K192667 · 2019-10-25

决定日期2019-10-25

产品代码QSY

决定实质等同

器械摘要

gel-e Flex+ gel OTC is the device name listed in this FDA 510(k) record. The listed applicant is Gel-E, Inc.. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K192667. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the gel-e Flex+ gel OTC?

gel-e Flex+ gel OTC is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Gel-E, Inc.. The 510(k) number is K192667.

When did gel-e Flex+ gel OTC receive FDA 510(k) clearance?

gel-e Flex+ gel OTC received FDA 510(k) clearance on 2019-10-25, under 510(k) number K192667.

Who is the listed applicant for gel-e Flex+ gel OTC?

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

What is the FDA product code for gel-e Flex+ gel OTC?

The FDA product code for gel-e Flex+ gel OTC is QSY.

列明Gel-E, 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。

K182811凝胶-e Flex+K180152凝胶-e 弹性

相关器械（代码：QSY）

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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