Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2120](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2120) → PHV — Continuous Glucose Monitor Retrospective Data Analysis Software

# PHV · Continuous Glucose Monitor Retrospective Data Analysis Software

_Clinical Chemistry · 21 CFR 862.2120 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/PHV

## Overview

- **Product Code:** PHV
- **Device Name:** Continuous Glucose Monitor Retrospective Data Analysis Software
- **Regulation:** [21 CFR 862.2120](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2120)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/PHV/DEN140016.md) | STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE | Dexcom, Inc. | Aug 19, 2014 | DENG |

## Top Applicants

- Dexcom, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/PHV](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/PHV)

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