# OZO · Automated Insulin Dosing , Threshold Suspend

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/OZO

## Overview

- **Product Code:** OZO
- **Device Name:** Automated Insulin Dosing , Threshold Suspend
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P180008](/device/P180008.md) | t:slim X2 Insulin Pump with Basal-IQ Technology | Tandem Diabetes Care, Inc. | Jun 21, 2018 | APPR |
| [P150001](/device/P150001.md) | MINIMED 630G SYSTEM WITH SMARTGUARD(TM) | Medtronic Minimed | Aug 10, 2016 | APPR |
| [P120010](/device/P120010.md) | MINIMED 530G SYSTEM | Medtronic, Inc. | Sep 26, 2013 | APPR |

## Top Applicants

- Medtronic Minimed — 1 clearance
- Medtronic, Inc. — 1 clearance
- Tandem Diabetes Care, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/OZO](https://fda.innolitics.com/productcode/OZO)

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