FDA 510(k)

IntelliVue 輔助儀器，IntelliVue 微流輔助儀器

K 號：K172904 · 2017-12-26

申請人Philips Medizin Systeme Boeblingen GmbH

決定日期2017-12-26

產品代碼CCK

諮詢委員會AN

決定相當於

器材摘要

IntelliVue Capnography Extension, IntelliVue Microstream Extension is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2017-12-26 under 510(k) number K172904. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IntelliVue Capnography Extension, IntelliVue Microstream Extension?

IntelliVue Capnography Extension, IntelliVue Microstream Extension is a medical device that received FDA 510(k) clearance on 2017-12-26. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K172904.

When did IntelliVue Capnography Extension, IntelliVue Microstream Extension receive FDA 510(k) clearance?

IntelliVue Capnography Extension, IntelliVue Microstream Extension received FDA 510(k) clearance on 2017-12-26, under 510(k) number K172904.

Who is the listed applicant for IntelliVue Capnography Extension, IntelliVue Microstream Extension?

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

What is the FDA product code for IntelliVue Capnography Extension, IntelliVue Microstream Extension?

The FDA product code for IntelliVue Capnography Extension, IntelliVue Microstream Extension is CCK.

其他以 Philips Medizin Systeme Boeblingen 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。

K252726IntelliVue 多測量模組 X3 (867030)；IntelliVue 患者監護儀 MX100 (867033)；IntelliVue MMX (867036)K251146IntelliVue 患者監護儀 MX400、MX450、MX500、MX550 K233440Avalon CL 胎兒與母親 (F&M) Pod (866488)，Avalon CL 胎兒與母親 (F&M) 贴片 (989803196341)K231671IntelliVue病人監護儀MX750（866471）、IntelliVue病人監護儀MX850（866470）、IntelliVue 4槽模組架FMX-4（866468）K230604IntelliVue 病患監護儀 MX100 (867033)，IntelliVue 多量測模組 X3 (867030)K223574IntelliVue病人監護儀MX400 (866060)，IntelliVue病人監護儀MX450 (866062)，IntelliVue病人監護儀MX500 (866064)，IntelliVue病人監護儀MX550 (866066)

查看所有 20 項裝置 →

相關器械（代碼：CCK）

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。

K251641GF-310R 多氣體單元（GF-310R）Nihon Kohden Corporation K261633視覺呼吸Affirm Medical Technologies II, LLC K253030Capnostream™35 輕便呼吸監測器 (PM35MN)Covidien, LLC K250148醫療氣體分析儀（AG200）Prior Care Science Technology, Ltd.K243956TG-980P 二氧化碳感測器套件（TG-980P）；TG-980P1 二氧化碳感測器套件（TG-980P1）Nihon Kohden Corporation K2512160184 CO2 標本採集管；0184T CO2 標本採集管；0139 CO2 標本採集管；0182 CO2 標本採集管Barbaras Development, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。