FDA 510(k)

Vivix-S FW（型号：FXRD-2530FAW，FXRD-3643FAW，FXRD-4343FAW）

K号: K221512 · 2022-07-20

决定日期2022-07-20

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) is the device name listed in this FDA 510(k) record. The listed applicant is Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2022-07-20 under 510(k) number K221512. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)?

Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) is a medical device that received FDA 510(k) clearance on 2022-07-20. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K221512.

When did Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) receive FDA 510(k) clearance?

Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) received FDA 510(k) clearance on 2022-07-20, under 510(k) number K221512.

Who is the listed applicant for Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)?

The FDA 510(k) record lists Vieworks Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)?

The FDA product code for Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) is MQB.

列明Vieworks 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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