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FDA 510(k)

InTouch 热成像相机

K号: K181716 · 2019-03-25

决定日期2019-03-25
产品代码LHQ
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决定实质等同

器械摘要

InTouch Thermal Camera is the device name listed in this FDA 510(k) record. The listed applicant is Intouch Technologies, Inc., D.B.A. Intouch Health. It received FDA 510(k) clearance on 2019-03-25 under 510(k) number K181716. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the InTouch Thermal Camera?

InTouch Thermal Camera is a medical device that received FDA 510(k) clearance on 2019-03-25. The listed applicant is Intouch Technologies, Inc., D.B.A. Intouch Health. The 510(k) number is K181716.

When did InTouch Thermal Camera receive FDA 510(k) clearance?

InTouch Thermal Camera received FDA 510(k) clearance on 2019-03-25, under 510(k) number K181716.

Who is the listed applicant for InTouch Thermal Camera?

The FDA 510(k) record lists Intouch Technologies, Inc., D.B.A. Intouch Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InTouch Thermal Camera?

The FDA product code for InTouch Thermal Camera is LHQ.

相关临床试验

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。

相关器械(代码:LHQ)

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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