FDA 510(k)

Chartis Precision 导管

K号: K222340 · 2022-12-01

决定日期2022-12-01

产品代码CBI

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Chartis Precision Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonx Corporation. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K222340. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Chartis Precision Catheter?

Chartis Precision Catheter is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Pulmonx Corporation. The 510(k) number is K222340.

When did Chartis Precision Catheter receive FDA 510(k) clearance?

Chartis Precision Catheter received FDA 510(k) clearance on 2022-12-01, under 510(k) number K222340.

Who is the listed applicant for Chartis Precision Catheter?

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 Chartis Precision Catheter?

The FDA product code for Chartis Precision Catheter is CBI.

列明Pulmonx Corporation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。

K253096Chartis Precision 导管 K212494肺影像分析 K180011Pulmonx Chartis Tablet Console

相关器械（代码：CBI）

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。

官方来源

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