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FDA 510(k)

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software

K 號：K232354 · 2024-03-22

申請人Murata Vios, Inc.
決定日期2024-03-22
產品代碼DRT
諮詢委員會CV
決定Substantially Equivalent

器材摘要

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software is the device name listed in this FDA 510(k) record. The listed applicant is Murata Vios, Inc.. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K232354. 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(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software?

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Murata Vios, Inc.. The 510(k) number is K232354.

When did Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software receive FDA 510(k) clearance?

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software received FDA 510(k) clearance on 2024-03-22, under 510(k) number K232354.

Who is the listed applicant for Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software?

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

What is the FDA product code for Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software?

The FDA product code for Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software is DRT.

相關臨床試驗

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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其他以 Murata Vios, 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。

K241728Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050

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(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

官方來源

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