K182405 is an FDA 510(k) clearance for the Dexcom Pro Q Continuous Glucose Monitoring System. This device is classified as a Integrated Continuous Glucose Monitoring System For Professional Retrospective Use (Class II - Special Controls, product code QDL).
Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on November 2, 2018, 59 days after receiving the submission on September 4, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1355. An Integrated Continuous Glucose Monitoring System For Professional Retrospective Use Is A Continuous Glucose Recording Device Indicated For The Retrospective Discovery, Analysis, And Interpretation Of Glycemic Variability In Persons Age 2 And Older For Use By Healthcare Professionals To Guide Appropriate Patient Management. The System Is Also Intended To Interface With Digitally Connected Devices..
| 510(k) Number | K182405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2018 |
| Decision Date | November 02, 2018 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QDL — Integrated Continuous Glucose Monitoring System For Professional Retrospective Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1355 |
| Definition | An Integrated Continuous Glucose Monitoring System For Professional Retrospective Use Is A Continuous Glucose Recording Device Indicated For The Retrospective Discovery, Analysis, And Interpretation Of Glycemic Variability In Persons Age 2 And Older For Use By Healthcare Professionals To Guide Appropriate Patient Management. The System Is Also Intended To Interface With Digitally Connected Devices. |