FDA 510(k)

EarlyVue VS30

K 號：K190624 · 2019-10-27

申請人Philips Medizin Systeme Boeblingen GmbH

決定日期2019-10-27

產品代碼DSJ

諮詢委員會履歷

決定相當於

器材摘要

EarlyVue VS30 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 2019-10-27 under 510(k) number K190624. The device is classified under product code DSJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EarlyVue VS30?

EarlyVue VS30 is a medical device that received FDA 510(k) clearance on 2019-10-27. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K190624.

When did EarlyVue VS30 receive FDA 510(k) clearance?

EarlyVue VS30 received FDA 510(k) clearance on 2019-10-27, under 510(k) number K190624.

Who is the listed applicant for EarlyVue VS30?

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 EarlyVue VS30?

The FDA product code for EarlyVue VS30 is DSJ.

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：DSJ）

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。

K163649SureSigns VS3；SureSigns VS4Philips Medical Systems

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。