FDA 510(k)

Opallis，Opallis Flow

K号: K201707 · 2020-12-22

决定日期2020-12-22

产品代码EBF

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决定实质等同

器械摘要

Opallis, Opallis Flow is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K201707. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Opallis, Opallis Flow?

Opallis, Opallis Flow is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Dentscare Ltda. The 510(k) number is K201707.

When did Opallis, Opallis Flow receive FDA 510(k) clearance?

Opallis, Opallis Flow received FDA 510(k) clearance on 2020-12-22, under 510(k) number K201707.

Who is the listed applicant for Opallis, Opallis Flow?

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 Opallis, Opallis Flow?

The FDA product code for Opallis, Opallis Flow is EBF.

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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