Dexcom Smart Basal— 510(k) K252818

Substantially Equivalent

Dexcom, Inc.

FDA 510(k) clearance K252818 for Dexcom Smart Basal, Substantially Equivalent on 2025-11-18. Applicant: Dexcom, Inc..

Clearance details

Applicant: Dexcom, Inc.
Product code: Code QRX
Advisory panel: Clinical Chemistry
Date received: 2025-09-04
Decision date: 2025-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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