FDA 510(k)

SmartLinx Vitals Plus 病患監護系統

K 號：K180734 · 2018-08-08

決定日期2018-08-08

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

SmartLinx Vitals Plus Patient Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Capsule Technologie. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K180734. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SmartLinx Vitals Plus Patient Monitoring System?

SmartLinx Vitals Plus Patient Monitoring System is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Capsule Technologie. The 510(k) number is K180734.

When did SmartLinx Vitals Plus Patient Monitoring System receive FDA 510(k) clearance?

SmartLinx Vitals Plus Patient Monitoring System received FDA 510(k) clearance on 2018-08-08, under 510(k) number K180734.

Who is the listed applicant for SmartLinx Vitals Plus Patient Monitoring System?

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

What is the FDA product code for SmartLinx Vitals Plus Patient Monitoring System?

The FDA product code for SmartLinx Vitals Plus Patient Monitoring System is MWI.

其他以 Capsule Technologie 為申請人之記錄

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K183638SmartLinx Vitals Plus 病患監護系統

相關器械（代碼：MWI）

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。

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官方來源

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