510(k) K182405
K182405 is an FDA 510(k) premarket notification submitted by Dexcom, Inc. for the device "Dexcom Pro Q Continuous Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on November 2, 2018. The device falls under product code QDL (Integrated Continuous Glucose Monitoring System For Professional Retrospective Use), a Class II device regulated under 21 CFR 862.1355. Dexcom, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2018
- Date Received
- September 4, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
- Device Class
- Class II
- Regulation Number
- 862.1355
- Review Panel
- CH
- Submission Type
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.