FDA 510(k)

Ambar, Ambar APS, Ambar Universal APS

K号: K183424 · 2019-12-13

决定日期2019-12-13

产品代码KLE

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决定实质等同

器械摘要

Ambar, Ambar APS, Ambar Universal APS is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K183424. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ambar, Ambar APS, Ambar Universal APS?

Ambar, Ambar APS, Ambar Universal APS is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Dentscare Ltda. The 510(k) number is K183424.

When did Ambar, Ambar APS, Ambar Universal APS receive FDA 510(k) clearance?

Ambar, Ambar APS, Ambar Universal APS received FDA 510(k) clearance on 2019-12-13, under 510(k) number K183424.

Who is the listed applicant for Ambar, Ambar APS, Ambar Universal APS?

The FDA 510(k) record lists Dentscare Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ambar, Ambar APS, Ambar Universal APS?

The FDA product code for Ambar, Ambar APS, Ambar Universal APS is KLE.

列明Dentscare Ltda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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