Continuous Glucose Monitor Retrospective Data Analysis Software
Continuous Glucose Monitor Retrospective Data Analysis Software is a software device intended to analyze and correlate retrospective data collected from a continuous glucose monitoring (CGM) system, helping clinicians and patients review glucose trends over time. It is an FDA Class 1 device regulated under 21 CFR 862.2120, subject to general controls, within the Clinical Chemistry (CH) medical specialty. The product code is PHV. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PHV
- Device Class
- FDA class 1
- Regulation Number
- 862.2120
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
Definition
Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN140016 | STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE | Aug 19, 2014 | Unknown | Dexcom, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.