FDA 510(k)

Dexcom G6 葡萄糖計劃連續葡萄糖監測（GCM）系統

K 號：K192787 · 2019-10-25

決定日期2019-10-25

產品代碼QDK

諮詢委員會CH

決定相當於

器材摘要

Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System is the device name listed in this FDA 510(k) record. The listed applicant is Dexcom, Inc.. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K192787. The device is classified under product code QDK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System?

Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Dexcom, Inc.. The 510(k) number is K192787.

When did Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System receive FDA 510(k) clearance?

Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System received FDA 510(k) clearance on 2019-10-25, under 510(k) number K192787.

Who is the listed applicant for Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System?

FDA 510(k) 記錄將 Dexcom, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System?

The FDA product code for Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System is QDK.

其他以 Dexcom, 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。

K262472Stelo 葡萄糖生物感測系統 K260935Stelo 葡萄糖生物感測系統 K261402Dexcom G7 持續血糖監測系統；Dexcom G7 15日持續血糖監測系統 K261359Stelo 葡萄糖生物感測系統 K253737Dexcom G7 持續血糖監測（CGM）系統；Dexcom G7 15日持續血糖監測（CGM）系統 K253710Dexcom G7 持續血糖監測（CGM）系統，Dexcom G7 15日持續血糖監測（CGM）系統

查看所有 25 項裝置 →

相關器械（代碼：QDK）

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。

K203089Dexcom G6 葡萄糖計劃連續葡萄糖監測（CGM）系統Dexcom, Inc.K193642Dexcom G6 葡萄糖計劃連續葡萄糖監測（CGM）系統Dexcom, Inc.K182041Dexcom G6 葡萄糖計劃連續葡萄糖監測系統Dexcom, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。