FDA 510(k)

Dexcom Smart Basal

K号: K252818 · 2025-11-18

决定日期2025-11-18

产品代码QRX

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决定实质等同

器械摘要

Dexcom Smart Basal is the device name listed in this FDA 510(k) record. The listed applicant is Dexcom, Inc.. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K252818. The device is classified under product code QRX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dexcom Smart Basal?

Dexcom Smart Basal is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Dexcom, Inc.. The 510(k) number is K252818.

When did Dexcom Smart Basal receive FDA 510(k) clearance?

Dexcom Smart Basal received FDA 510(k) clearance on 2025-11-18, under 510(k) number K252818.

Who is the listed applicant for Dexcom Smart Basal?

FDA 510(k)记录中列出Dexcom，Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Dexcom Smart Basal?

The FDA product code for Dexcom Smart Basal is QRX.

列明Dexcom, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262472Stelo葡萄糖生物传感器系统 K260935Stelo葡萄糖生物传感器系统 K261402Dexcom G7 连续葡萄糖监测系统；Dexcom G7 15天连续葡萄糖监测系统 K261359Stelo葡萄糖生物传感器系统 K253737Dexcom G7 连续葡萄糖监测（CGM）系统；Dexcom G7 15天连续葡萄糖监测（CGM）系统 K253710Dexcom G7 连续葡萄糖监测（CGM）系统，Dexcom G7 15天连续葡萄糖监测（CGM）系统

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