FDA device listing
Automated Insulin Dosing Device System, Single Hormonal Control
FDA device listing 1302875551 · INTRICON CORPORATION
Key facts
| Owner/operator | INTRICON CORPORATION |
|---|---|
| Owner/operator number | 9039676 |
| Product codes | OZP |
| Device names | OZP - Automated Insulin Dosing Device System, Single Hormonal Control |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OZP |
| Review panels | Clinical Chemistry |
| Registered establishments | INTRICON CORPORATION, IntriCon Corporation Grey Fox |
| Establishment registrations | 2134850, 3014498598 |
| FEI numbers | 3003007876, 3014498598 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database