FDA 510(k)

飛利浦 IntelliVue 監護軟體（修訂版 E.0X）

K 號：K212208 · 2021-09-30

申請人Philips Medizin Systeme Boeblingen GmbH

決定日期2021-09-30

產品代碼DXJ

諮詢委員會履歷

決定相當於

器材摘要

Philips IntelliVue GuardianSoftware (Rev. E.0X) 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 2021-09-30 under 510(k) number K212208. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Philips IntelliVue GuardianSoftware (Rev. E.0X)?

Philips IntelliVue GuardianSoftware (Rev. E.0X) is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K212208.

When did Philips IntelliVue GuardianSoftware (Rev. E.0X) receive FDA 510(k) clearance?

Philips IntelliVue GuardianSoftware (Rev. E.0X) received FDA 510(k) clearance on 2021-09-30, under 510(k) number K212208.

Who is the listed applicant for Philips IntelliVue GuardianSoftware (Rev. E.0X)?

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 GuardianSoftware (Rev. E.0X)?

The FDA product code for Philips IntelliVue GuardianSoftware (Rev. E.0X) is DXJ.

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：DXJ）

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。

K212003ESSENZ 患者監護儀Livanova Deutschland, GmbH K201162Essence 55SP 大螢幕系統Shenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios中央監控站監控軟體，Vios中央伺服器軟體Vios Medical, Inc.K180534飛利浦 IntelliVue 監護軟體Philips Medizin Systeme Boeblingen GmbH K173381Nexxis ORBarco N.V.K172969Essence 55S 大螢幕系統Shenyang Torch-Bigtide Digital Technology Co., Ltd.

官方來源

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