Dexcom G6 Pro Continuous Glucose Monitoring System— 510(k) K191833
Substantially EquivalentDexcom, Inc.
FDA 510(k) clearance K191833 for Dexcom G6 Pro Continuous Glucose Monitoring System, Substantially Equivalent on 2019-10-07. Applicant: Dexcom, Inc.. Device class: 2.
Clearance details
- Applicant
- Dexcom, Inc.
- Product code
- Code QII
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.