Eversense 365连续葡萄糖监测（CGM）系统
K号: K241335 · 2024-09-16
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决定日期2024-09-16
产品代码SBA
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
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器械摘要
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.
常见问题
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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