FDA 510(k)

LED固化灯

K号: K192233 · 2020-02-13

申请人Foshan Cicada Dental Instrument Co, Ltd.

决定日期2020-02-13

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 Foshan Cicada Dental Instrument Co, Ltd.. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K192233. 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 2020-02-13. The listed applicant is Foshan Cicada Dental Instrument Co, Ltd.. The 510(k) number is K192233.

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

LED Curing Light received FDA 510(k) clearance on 2020-02-13, under 510(k) number K192233.

Who is the listed applicant for LED Curing Light?

The FDA 510(k) record lists Foshan Cicada Dental Instrument 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Foshan Cicada Dental Instrument 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。

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