510(k) DEN140016
- Device
- STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
- Applicant
- Dexcom, Inc.
- 510(k) number
- DEN140016
- Product code
- PHV
- Decision
- Unknown (DENG)
- Decision date
- 2014-08-19
- Date received
- 2014-04-22
- Regulation
- 862.2120
- Classification name
- Continuous Glucose Monitor Retrospective Data Analysis Software
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- ANDREW BALO
- Address
- 6340 Sequence Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3008770957
- 3009137498
- 3024580094
- 3004753838
- 2032227
- 3016525500
- 3007981285
- 3013922904
- 3014642500
- 3028170577
- 3012128418
- 3014585508
- 3021611414
- 2954323
- 3009862700
Source Documents#
510(k) summary PDF not indicated by FDA