FDA 510(k)

LED固化灯

K号: K161855 · 2017-11-27

决定日期2017-11-27

产品代码EBZ

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决定实质等同

器械摘要

LED Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Monitex Industrial Co., Ltd.. It received FDA 510(k) clearance on 2017-11-27 under 510(k) number K161855. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LED Curing Light?

LED Curing Light is a medical device that received FDA 510(k) clearance on 2017-11-27. The listed applicant is Monitex Industrial Co., Ltd.. The 510(k) number is K161855.

When did LED Curing Light receive FDA 510(k) clearance?

LED Curing Light received FDA 510(k) clearance on 2017-11-27, under 510(k) number K161855.

Who is the listed applicant for LED Curing Light?

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

What is the FDA product code for LED Curing Light?

The FDA product code for LED Curing Light is EBZ.

列明Monitex Industrial Co., 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。

K152192LED固化灯 K153078LED固化灯GT-2000

官方来源

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