FDA 510(k)

维特拉810

K号: K201502 · 2020-08-06

决定日期2020-08-06

产品代码HQF

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决定实质等同

器械摘要

Vitra 810 is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K201502. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vitra 810?

Vitra 810 is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Quantel Medical. The 510(k) number is K201502.

When did Vitra 810 receive FDA 510(k) clearance?

Vitra 810 received FDA 510(k) clearance on 2020-08-06, under 510(k) number K201502.

Who is the listed applicant for Vitra 810?

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

What is the FDA product code for Vitra 810?

The FDA product code for Vitra 810 is HQF.

列明Quantel Medical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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