PHV · Continuous Glucose Monitor Retrospective Data Analysis Software
Clinical Chemistry · 21 CFR 862.2120 · Class 1
Overview
| Product Code | PHV |
|---|---|
| Device Name | Continuous Glucose Monitor Retrospective Data Analysis Software |
| Regulation | 21 CFR 862.2120 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A continuous glucose monitor data management system is an electronic device intended to acquire, process, and correlate retrospective data from a continuous glucose monitoring device. This device is intended to be used by patients or their healthcare providers when determining therapeutic strategies. A continuous glucose monitor data management system is not a drug dose calculator and does not provide treatment recommendations.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN140016 | STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE | Dexcom, Inc. | Aug 19, 2014 | DENG |
Top Applicants
- Dexcom, Inc. — 1 clearance
