FDA 510(k)

tremoflo C2 氣波振盪儀系統

K 號：K221024 · 2023-06-20

申請人Thorasys Thoracic Medical Systems, Inc.

決定日期2023-06-20

產品代碼PNV

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 Thorasys Thoracic Medical Systems, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：PNV）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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