FDA 510(k)

Tremoflo C2 Airwave 振动描记系统

K号: K221024 · 2023-06-20

申请人Thorasys Thoracic Medical Systems, Inc.

决定日期2023-06-20

产品代码PNV

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决定实质等同

器械摘要

tremoflo C2 Airwave Oscillometry System is the device name listed in this FDA 510(k) record. The listed applicant is Thorasys Thoracic Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K221024. The device is classified under product code PNV. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the tremoflo C2 Airwave Oscillometry System?

tremoflo C2 Airwave Oscillometry System is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Thorasys Thoracic Medical Systems, Inc.. The 510(k) number is K221024.

When did tremoflo C2 Airwave Oscillometry System receive FDA 510(k) clearance?

tremoflo C2 Airwave Oscillometry System received FDA 510(k) clearance on 2023-06-20, under 510(k) number K221024.

Who is the listed applicant for tremoflo C2 Airwave Oscillometry System?

The FDA 510(k) record lists Thorasys Thoracic Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for tremoflo C2 Airwave Oscillometry System?

The FDA product code for tremoflo C2 Airwave Oscillometry System is PNV.

列明Thorasys Thoracic Medical Systems, Inc.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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