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FDA 510(k)

肺影像分析

K号: K212494 · 2021-09-02

决定日期2021-09-02
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

Lung Image Analysis is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonx Corporation. It received FDA 510(k) clearance on 2021-09-02 under 510(k) number K212494. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lung Image Analysis?

Lung Image Analysis is a medical device that received FDA 510(k) clearance on 2021-09-02. The listed applicant is Pulmonx Corporation. The 510(k) number is K212494.

When did Lung Image Analysis receive FDA 510(k) clearance?

Lung Image Analysis received FDA 510(k) clearance on 2021-09-02, under 510(k) number K212494.

Who is the listed applicant for Lung Image Analysis?

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

What is the FDA product code for Lung Image Analysis?

The FDA product code for Lung Image Analysis is JAK.

相关临床试验

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列明Pulmonx Corporation为申报人的其他记录

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相关器械(代码:JAK)

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官方来源

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