FDA 510(k)

馬西莫W1

K 號：K243305 · 2025-04-03

決定日期2025-04-03

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

Masimo W1 is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2025-04-03 under 510(k) number K243305. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Masimo W1?

Masimo W1 is a medical device that received FDA 510(k) clearance on 2025-04-03. The listed applicant is Masimo Corporation. The 510(k) number is K243305.

When did Masimo W1 receive FDA 510(k) clearance?

Masimo W1 received FDA 510(k) clearance on 2025-04-03, under 510(k) number K243305.

Who is the listed applicant for Masimo W1?

FDA 510(k) 記錄中將 Masimo Corporation 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Masimo W1?

The FDA product code for Masimo W1 is DPS.

其他以 Masimo Corporation 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。

K253417馬斯美Root監控系統 K260880SedLine 鎮靜監護儀 K254209Radius VSM 及其附件 K243324馬斯米O3地區性血氧儀 K250757Radius VSM 及其附件 K240229馬西莫W1

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相關器械（代碼：DPS）

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。

K254255S-Patch 心臟AIWellysis Corp.K252463SE-1202系列心電圖儀（型號：SE-1202，SE-1202E）Edan Instruments, Inc.K251670MAC 7 靜息心電圖分析系統Ge Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs 霍爾特平台Philips France Commercial

官方來源

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