FDA 510(k)

Vista Solution 監控套件，Vista Solution 2 10天評估套件，VistaTablet 2（盒裝）

K 號：K193343 · 2020-04-20

決定日期2020-04-20

產品代碼DRG

諮詢委員會履歷

決定相當於

器材摘要

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) is the device name listed in this FDA 510(k) record. The listed applicant is Vitalconnect, Inc.. It received FDA 510(k) clearance on 2020-04-20 under 510(k) number K193343. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)?

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) is a medical device that received FDA 510(k) clearance on 2020-04-20. The listed applicant is Vitalconnect, Inc.. The 510(k) number is K193343.

When did Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) receive FDA 510(k) clearance?

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) received FDA 510(k) clearance on 2020-04-20, under 510(k) number K193343.

Who is the listed applicant for Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)?

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

What is the FDA product code for Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)?

The FDA product code for Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) is DRG.

其他以 Vitalconnect, Inc. 為申請人之記錄

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相關器械（代碼：DRG）

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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