FDA 510(k)

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System

N.º K: K193642 · 2020-01-29

Fecha de decisión2020-01-29

Código de productoQDK

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) 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 2020-01-29 under 510(k) number K193642. The device is classified under product code QDK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is Dexcom, Inc.. The 510(k) number is K193642.

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

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System received FDA 510(k) clearance on 2020-01-29, under 510(k) number K193642.

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

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

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

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

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Otros registros que enlistan a Dexcom, Inc. como solicitante

K262472Stelo Glucose Biosensor System K260935Stelo Glucose Biosensor System K261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System K261359Stelo Glucose Biosensor System K253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System

Ver todos los 25 dispositivos →

Dispositivos relacionados (Código: QDK)

K203089Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.K192787Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) SystemDexcom, Inc.K182041Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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