510(k) DEN140038
- Device
- Dexcom Share Direct Secondary Displays
- Applicant
- Dexcom, Inc.
- 510(k) number
- DEN140038
- Product code
- PJT
- Decision
- Unknown (DENG)
- Decision date
- 2015-01-23
- Date received
- 2014-12-15
- Regulation
- 862.1350
- Classification name
- Continuous Glucose Monitor Secondary Display
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Andrew K Balo
- Address
- 6340 Sequence Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3008770957
- 3004753838
- 2134850
- 2032227
- 3028013069
- 3007981285
- 3014700242
- 3017181032
- 3031700059
- 2954323
- 3009862700
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PJT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151236 | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) | Medtronic Minimed, Inc. | 2015-05-19 |