FDA 510(k)

飛利浦 IntelliVue XDS 軟體

K 號：K182637 · 2019-04-26

申請人Philips Medizin Systeme Boeblingen GmbH

決定日期2019-04-26

產品代碼MSX

諮詢委員會履歷

決定相當於

器材摘要

Philips IntelliVue XDS Software 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 2019-04-26 under 510(k) number K182637. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Philips IntelliVue XDS Software?

Philips IntelliVue XDS Software is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K182637.

When did Philips IntelliVue XDS Software receive FDA 510(k) clearance?

Philips IntelliVue XDS Software received FDA 510(k) clearance on 2019-04-26, under 510(k) number K182637.

Who is the listed applicant for Philips IntelliVue XDS Software?

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 Philips IntelliVue XDS Software?

The FDA product code for Philips IntelliVue XDS Software is MSX.

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)

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相關器械（代碼：MSX）

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。

K261287數位統計護理Ascom Ums Srl Unipersonale K260211儀表板（P007000）Hill-Rom, Inc.K261367柯薩諾 CardioWatch 287-2 系統Corsano Health B.V.K253654IntelliVue測量架6000（867317）Philips Medizin Systeme Böblingen GmbH K243270虎連接警報管理Tigerconnect K242728BeneVision 中央監控系統Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

官方來源

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