FDA 510(k)

Demetra Dermatoscope BDEM-01

K号: K213957 · 2022-03-11

决定日期2022-03-11

产品代码PSN

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决定实质等同

器械摘要

Demetra Dermatoscope BDEM-01 is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K213957. The device is classified under product code PSN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Demetra Dermatoscope BDEM-01?

Demetra Dermatoscope BDEM-01 is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Barco N.V.. The 510(k) number is K213957.

When did Demetra Dermatoscope BDEM-01 receive FDA 510(k) clearance?

Demetra Dermatoscope BDEM-01 received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213957.

Who is the listed applicant for Demetra Dermatoscope BDEM-01?

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

What is the FDA product code for Demetra Dermatoscope BDEM-01?

The FDA product code for Demetra Dermatoscope BDEM-01 is PSN.

列明Barco N.V.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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官方来源

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