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FDA 510(k)

Thermidas红外系统(ThIR-A615)

K号: K200999 · 2021-01-06

决定日期2021-01-06
产品代码LHQ
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决定实质等同

器械摘要

Thermidas IR System (ThIR-A615) is the device name listed in this FDA 510(k) record. The listed applicant is Thermidas Americas, Inc.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K200999. 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 Thermidas IR System (ThIR-A615)?

Thermidas IR System (ThIR-A615) is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Thermidas Americas, Inc.. The 510(k) number is K200999.

When did Thermidas IR System (ThIR-A615) receive FDA 510(k) clearance?

Thermidas IR System (ThIR-A615) received FDA 510(k) clearance on 2021-01-06, under 510(k) number K200999.

Who is the listed applicant for Thermidas IR System (ThIR-A615)?

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

What is the FDA product code for Thermidas IR System (ThIR-A615)?

The FDA product code for Thermidas IR System (ThIR-A615) is LHQ.

相关临床试验

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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。

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