Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System— 510(k) K192787
Substantially EquivalentDexcom, Inc.
FDA 510(k) clearance K192787 for Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System, Substantially Equivalent on 2019-10-25. Applicant: Dexcom, Inc.. Device class: 2.
Clearance details
- Applicant
- Dexcom, Inc.
- Product code
- Code QDK
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Recent devices under product code QDK
view allMore clearances from Dexcom, Inc.
view all- K262472 — Stelo Glucose Biosensor System
- K260935 — Stelo Glucose Biosensor System
- K261402 — Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System
- K261359 — Stelo Glucose Biosensor System
- K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
Adverse events under product code QDK
product code QDK- Malfunction
- 578
- Total
- 578
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.