FDA 510(k)

飛利浦 Efficia CMS200 中心監控系統

K 號：K160951 · 2016-05-05

決定日期2016-05-05

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Philips Efficia CMS200 Central Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K160951. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Philips Efficia CMS200 Central Monitoring System?

Philips Efficia CMS200 Central Monitoring System is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Philips Medical Systems. The 510(k) number is K160951.

When did Philips Efficia CMS200 Central Monitoring System receive FDA 510(k) clearance?

Philips Efficia CMS200 Central Monitoring System received FDA 510(k) clearance on 2016-05-05, under 510(k) number K160951.

Who is the listed applicant for Philips Efficia CMS200 Central Monitoring System?

The FDA 510(k) record lists Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Efficia CMS200 Central Monitoring System?

The FDA product code for Philips Efficia CMS200 Central Monitoring System is MHX.

其他以 Philips Medical Systems 為申請人之記錄

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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

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