K231081 is an FDA 510(k) clearance for the Dexcom G7 Continuous Glucose Monitoring (CGM) System. This device is classified as a Integrated Continuous Glucose Monitoring System, Factory Calibrated (Class II - Special Controls, product code QBJ).
Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on May 15, 2023, 28 days after receiving the submission on April 17, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1355. An Integrated Continuous Glucose Monitoring System (icgm) Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. Icgm Systems Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Including Automated Insulin Dosing Systems, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices For The Purpose Of Managing A Disease Or Condition Related To Glycemic Control..
| 510(k) Number | K231081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2023 |
| Decision Date | May 15, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QBJ — Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1355 |
| Definition | An Integrated Continuous Glucose Monitoring System (icgm) Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. Icgm Systems Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Including Automated Insulin Dosing Systems, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices For The Purpose Of Managing A Disease Or Condition Related To Glycemic Control. |