FDA 510(k)

dpl SpotLite

K号: K183118 · 2019-02-07

决定日期2019-02-07

产品代码OLP

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决定实质等同

器械摘要

dpl SpotLite is the device name listed in this FDA 510(k) record. The listed applicant is Led Technologies, Inc.. It received FDA 510(k) clearance on 2019-02-07 under 510(k) number K183118. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the dpl SpotLite?

dpl SpotLite is a medical device that received FDA 510(k) clearance on 2019-02-07. The listed applicant is Led Technologies, Inc.. The 510(k) number is K183118.

When did dpl SpotLite receive FDA 510(k) clearance?

dpl SpotLite received FDA 510(k) clearance on 2019-02-07, under 510(k) number K183118.

Who is the listed applicant for dpl SpotLite?

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

What is the FDA product code for dpl SpotLite?

The FDA product code for dpl SpotLite is OLP.

列明Led Technologies, 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。

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相关器械（代码：OLP）

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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