FDA 510(k)

Vios監控系統™ 型號 2050

K 號：K172586 · 2018-06-22

決定日期2018-06-22

產品代碼DRT

諮詢委員會履歷

決定相當於

器材摘要

Vios Monitoring System™ Model 2050 is the device name listed in this FDA 510(k) record. The listed applicant is Vios Medical, Inc.. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K172586. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vios Monitoring System™ Model 2050?

Vios Monitoring System™ Model 2050 is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Vios Medical, Inc.. The 510(k) number is K172586.

When did Vios Monitoring System™ Model 2050 receive FDA 510(k) clearance?

Vios Monitoring System™ Model 2050 received FDA 510(k) clearance on 2018-06-22, under 510(k) number K172586.

Who is the listed applicant for Vios Monitoring System™ Model 2050?

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

What is the FDA product code for Vios Monitoring System™ Model 2050?

The FDA product code for Vios Monitoring System™ Model 2050 is DRT.

其他以 Vios Medical, Inc. 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。

K173107Vios中央監控站監控軟體，Vios中央伺服器軟體

相關器械（代碼：DRT）

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。

K254058DistaSense™ (v1)Life Detection Technologies K261286Circadia C300 系統（C300）Circadia Health, Inc.K252676Circadia C300 系統（C300）Circadia Health, Inc.K253388Sleepiz One+（型號 2.5）Sleepiz AG K251364Sleepiz One+ (2.5)Sleepiz AG K234003Circadia C200 系統Circadia Technologies, Ltd.

官方來源

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