FDA 510(k)

Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System

N.º K: K253737 · 2026-02-03

Fecha de decisión2026-02-03

Código de productoQBJ

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day 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 2026-02-03 under 510(k) number K253737. The device is classified under product code QBJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System?

Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System is a medical device that received FDA 510(k) clearance on 2026-02-03. The listed applicant is Dexcom, Inc.. The 510(k) number is K253737.

When did Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System receive FDA 510(k) clearance?

Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System received FDA 510(k) clearance on 2026-02-03, under 510(k) number K253737.

Who is the listed applicant for Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day 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 G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System?

The FDA product code for Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System is QBJ.

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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 K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System K252818Dexcom Smart Basal

Ver todos los 25 dispositivos →

Dispositivos relacionados (Código: QBJ)

K261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc.K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc.K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.K240902Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.K234133Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.

Fuente oficial

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