Clearance Summary
Dexcom G6 Continuous Glucose Monitoring (CGM) System received FDA 510(k) clearance under submission number K201328, sponsored by Dexcom, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2021-07-15.
- Submission: K201328
- Applicant / Sponsor: Dexcom, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1355
- Decision date: 2021-07-15
Classification & Regulation
This clearance is catalogued under FDA product code QBJ and 21 CFR 862.1355, within the Clinical Chemistry review panel as a Class II device.