FDA 510(k)

SureSigns VS3；SureSigns VS4

K 號：K163649 · 2017-03-31

決定日期2017-03-31

產品代碼DSJ

諮詢委員會履歷

決定相當於

器材摘要

SureSigns VS3; SureSigns VS4 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K163649. 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 SureSigns VS3; SureSigns VS4?

SureSigns VS3; SureSigns VS4 is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Philips Medical Systems. The 510(k) number is K163649.

When did SureSigns VS3; SureSigns VS4 receive FDA 510(k) clearance?

SureSigns VS3; SureSigns VS4 received FDA 510(k) clearance on 2017-03-31, under 510(k) number K163649.

Who is the listed applicant for SureSigns VS3; SureSigns VS4?

The FDA 510(k) record lists Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureSigns VS3; SureSigns VS4?

The FDA product code for SureSigns VS3; SureSigns VS4 is DSJ.

其他以 Philips Medical Systems 為申請人之記錄

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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。

K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH

官方來源

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