FDA Registration
Active
🇺🇸 United States
Dexcom G7 Continuous Glucose Monitoring System
Reg #: 3013435121
·
FEI: 3013435121
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Dexcom, Inc.
- Registration Number
- 3013435121
- FEI Number
- 3013435121
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 232 South Dobson Road
- City
- Mesa
- State
- AZ
- ZIP
- 85202
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213919
Owner / Operator
- Firm Name
- DEXCOM, INC.
- Operator Number
- 9071756
- Address
- 6340 Sequence Drive, --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Tim Peterson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2023-01-30 |
Proprietary Names
Dexcom G7 Continuous Glucose Monitoring System
Establishment Types
Manufacture Medical Device