K-number	K192787
Device name	Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
Applicant	Dexcom, Inc.
Product code	QDK
Device class	Class II
Decision date	Oct 25, 2019
Decision	Substantially Equivalent
Regulation	862.1355

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System

Everything you need for a 510(k) submission. Nothing you don't.