FDA 510(k)

FloTrac感測器；FloTrac Jr感測器；Acumen IQ感測器；VolumeView感測器

K 號：K242909 · 2025-03-21

決定日期2025-03-21

產品代碼DRS

諮詢委員會履歷

決定相當於

器材摘要

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors 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 2025-03-21 under 510(k) number K242909. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors?

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K242909.

When did FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors receive FDA 510(k) clearance?

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors received FDA 510(k) clearance on 2025-03-21, under 510(k) number K242909.

Who is the listed applicant for FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors?

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 FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors?

The FDA product code for FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors is DRS.

其他以 Edwards Lifesciences, LLC 為申請人之記錄

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相關器械（代碼：DRS）

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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