FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
K Number: DEN140016
·
Decision Aug 19, 2014
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
0
Applicant Total
27
Review Days
119
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Basic Information
- Device Name
- STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
- K Number
- DEN140016
- Device Class
- FDA class 1
- Clearance Type
- Direct
- Regulation Number
- 862.2120
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Applicant
- Dexcom, Inc.
- Date Received
- April 22, 2014
- Decision Date
- August 19, 2014
- Product Code
- PHV
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software | FDA class 1 | Clinical Chemistry |
Other Clearances by Dexcom, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260935 | Stelo Glucose Biosensor System | Jun 12, 2026 | Substantially Equivalent |
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Jun 8, 2026 | Substantially Equivalent |
| K261359 | Stelo Glucose Biosensor System | May 21, 2026 | Substantially Equivalent |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Feb 3, 2026 | Substantially Equivalent |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dec 17, 2025 | Substantially Equivalent |
| K252818 | Dexcom Smart Basal | Nov 18, 2025 | Substantially Equivalent |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System | Apr 9, 2025 | Substantially Equivalent |
| K240902 | Dexcom G7 Continuous Glucose Monitoring System | Apr 23, 2024 | Substantially Equivalent |
| K234070 | Stelo Glucose Biosensor System | Mar 5, 2024 | Substantially Equivalent |
| K234133 | Dexcom G7 Continuous Glucose Monitoring System | Feb 26, 2024 | Substantially Equivalent |