FDA 510(k)

監視器 B105M；監視器 B125M；監視器 B155M；監視器 B105P；監視器 B125P

K 號：K242562 · 2025-07-09

申請人Ge Medical Systems Information Technologies, Inc.

決定日期2025-07-09

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2025-07-09 under 510(k) number K242562. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

Monitor B105M；Monitor B125M；Monitor B155M；Monitor B105P；Monitor B125P 是什麼？

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is a medical device that received FDA 510(k) clearance on 2025-07-09. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K242562.

Monitor B105M；Monitor B125M；Monitor B155M；Monitor B105P；Monitor B125P 當時是何時獲得 FDA 510(k) 識別許可的？

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P received FDA 510(k) clearance on 2025-07-09, under 510(k) number K242562.

誰是Monitor B105M；Monitor B125M；Monitor B155M；Monitor B105P；Monitor B125P的登記申請人？

FDA 510(k) 記錄將 Ge Medical Systems Information Technologies, Inc. 列為申請人。這並不單獨確立設備製造商。

FDA產品代碼是什麼？Monitor B105M；Monitor B125M；Monitor B155M；Monitor B105P；Monitor B125P？

FDA產品代碼為Monitor B105M；Monitor B125M；Monitor B155M；Monitor B105P；Monitor B125P的是MHX。

其他以 Ge Medical Systems Information Technologies, 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。

K253277監視器 B105M；監視器 B125M；監視器 B155M；監視器 B105P；監視器 B125P K251670MAC 7 靜息心電圖分析系統 K243540Mac-Lab (AltiX AI.i)；CardioLab (AltiX AI.i)；ComboLab (AltiX AI.i)；MLCL客戶軟體（AltiX AI.i）K233810Portait VSM K234130Portrait™ 行動監測解決方案包括： • Portrait™ 中央視覺應用程序 (Portrait CVAXB) • Portrait™ 核心服務 (Portrait CSSXB) • Portrait™ 醫療警示單元 (Portrait CAU01) • Portrait™ 行動病人監護硬體 (Portrait HUBXB) • Portrait™ 行動病人監護軟體 (Portrait HSWXB) • Portrait™ 可穿戴血氧濃度感測器 (Portrait SpO2 P-SA01) • Portrait™ 可穿戴血氧濃度感測器 (Portrait SpO2 P-SP01) • Portrait™ 可穿戴血氧濃度感測器 (Portrait SpO2 P-SP02)K231870CASE V7.0 心臟檢測系統及 CardioSoft V7.0 心臟檢測系統

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相關器械（代碼：MHX）

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。

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy K260343Carescape Canvas 1000；Carescape Canvas 智能顯示器GE Healthcare Finland Oy K260579Infinity® 急性照護系統 (IACS) – VG8.1Draeger Medical Systems, Inc.K251508遙測監視器（iT30，iT50）Edan Instruments, Inc.K253277監視器 B105M；監視器 B125M；監視器 B155M；監視器 B105P；監視器 B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM 及其附件Masimo Corporation

官方來源

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