Source document or public record
FDA 510(k) K231081 — Dexcom G7 Continuous Glucose Monitoring (CGM) System
FDA 510(k) index record K231081. Device: Dexcom G7 Continuous Glucose Monitoring (CGM) System. Applicant as listed: Dexcom, Inc.. Decision date: 2023-05-15.
Source
"device_name": "Dexcom G7 Continuous Glucose Monitoring (CGM) System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K231081.
Device name: Dexcom G7 Continuous Glucose Monitoring (CGM) System. Applicant as listed: Dexcom, Inc..
Decision date: 2023-05-15. Decision wording: Substantially Equivalent.
Product code: QBJ. Regulation: 21 CFR 862.1355. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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