FDA 510(k)

IntelliVue病人監護儀6100（6100）；IntelliVue病人監護儀6300（6300）；IntelliVue病人監護儀6500（6500）

K 號：K250453 · 2025-09-02

申請人Philips Medizin Systeme Böblingen GmbH

決定日期2025-09-02

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Böblingen GmbH. It received FDA 510(k) clearance on 2025-09-02 under 510(k) number K250453. 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 IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)?

IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) is a medical device that received FDA 510(k) clearance on 2025-09-02. The listed applicant is Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K250453.

When did IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) receive FDA 510(k) clearance?

IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) received FDA 510(k) clearance on 2025-09-02, under 510(k) number K250453.

Who is the listed applicant for IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)?

The FDA 510(k) record lists Philips Medizin Systeme Böblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)?

The FDA product code for IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) is MHX.

其他以 Philips Medizin Systeme Böblingen GmbH 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。

K252821可重用成人SpO2夾式感測器（3m）（M1196A）；可重用成人SpO2夾式感測器（0.9m）（M1196T）K253654IntelliVue測量架6000（867317）K251702IntelliVue病人監護儀MX750；IntelliVue病人監護儀MX850；IntelliVue 4槽模組架FMX-4（866471 866470 866468）K242962遙測監視器 5500 版本 4.0 (867232)K241890飛利浦心電圖分析系統 K243545飛利浦可重用心電圖導联組及樹幹電纜：型號編號、型號名稱：989803170171，或3導心電樹幹電纜，AAMI/IEC；989803170181，或5導心電樹幹電纜，AAMI/IEC；M1667A，6導心電樹幹，AAMI/IEC 2.7m；M1668A，5導心電樹幹，AAMI/IEC 2.7m；M1669A，3導心電樹幹，AAMI/IEC 2.7m；M1949A，5+5心電樹幹電纜 AAMI，IEC 2.7m；M1663A，10導心電樹幹 AAMI/IEC 2m；M1665A，6+4導心電樹幹 AAMI/IEC 2.7m；M1671A，3導聯組，抓取器，AAMI，ICU；M1673A，3導聯組，Sn

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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。

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