OZO · Automated Insulin Dosing , Threshold Suspend
· Class 3
Overview
| Product Code | OZO |
|---|---|
| Device Name | Automated Insulin Dosing , Threshold Suspend |
| Device Class | Class 3 |
| Review Panel |
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 | t:slim X2 Insulin Pump with Basal-IQ Technology | Tandem Diabetes Care, Inc. | Jun 21, 2018 | APPR |
| P150001 | MINIMED 630G SYSTEM WITH SMARTGUARD(TM) | Medtronic Minimed | Aug 10, 2016 | APPR |
| P120010 | 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
