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FDA 510(k)

Eversense 365 Continuous Glucose Monitoring (CGM) System

Número K: K241335 · 2024-09-16

RequerenteSenseonics, Incorporated
Data da decisão2024-09-16
Código do produtoSBA
Comité consultivoCH
DecisãoSubstantially Equivalent

Resumo do dispositivo

Eversense 365 Continuous Glucose Monitoring (CGM) System is the device name listed in this FDA 510(k) record. The listed applicant is Senseonics, Incorporated. It received FDA 510(k) clearance on 2024-09-16 under 510(k) number K241335. The device is classified under product code SBA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Eversense 365 Continuous Glucose Monitoring (CGM) System?

Eversense 365 Continuous Glucose Monitoring (CGM) System is a medical device that received FDA 510(k) clearance on 2024-09-16. The listed applicant is Senseonics, Incorporated. The 510(k) number is K241335.

When did Eversense 365 Continuous Glucose Monitoring (CGM) System receive FDA 510(k) clearance?

Eversense 365 Continuous Glucose Monitoring (CGM) System received FDA 510(k) clearance on 2024-09-16, under 510(k) number K241335.

Who is the listed applicant for Eversense 365 Continuous Glucose Monitoring (CGM) System?

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

What is the FDA product code for Eversense 365 Continuous Glucose Monitoring (CGM) System?

The FDA product code for Eversense 365 Continuous Glucose Monitoring (CGM) System is SBA.

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