510(k) K182405
- Device
- Dexcom Pro Q Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc
- 510(k) number
- K182405
- Product code
- QDL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-02
- Date received
- 2018-09-04
- Regulation
- 862.1355
- Classification name
- Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Luke Olson
- Address
- 6310 Sequence Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 2024024
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary