FDA 510(k)

真波一次性壓力傳感器

K 號：K222216 · 2022-12-22

決定日期2022-12-22

產品代碼DXO

諮詢委員會履歷

決定相當於

器材摘要

TruWave Disposable Pressure Transducer is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2022-12-22 under 510(k) number K222216. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TruWave Disposable Pressure Transducer?

TruWave Disposable Pressure Transducer is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K222216.

When did TruWave Disposable Pressure Transducer receive FDA 510(k) clearance?

TruWave Disposable Pressure Transducer received FDA 510(k) clearance on 2022-12-22, under 510(k) number K222216.

Who is the listed applicant for TruWave Disposable Pressure Transducer?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TruWave Disposable Pressure Transducer?

The FDA product code for TruWave Disposable Pressure Transducer is DXO.

其他以 Edwards Lifesciences, LLC 為申請人之記錄

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相關器械（代碼：DXO）

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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