FDA device listing
Tempo Smart Button
FDA device listing 1872618659 · Flextronics International USA, Inc.
Key facts
| Proprietary names | Tempo Smart Button |
|---|---|
| Owner/operator | Flextronics International USA, Inc. |
| Owner/operator number | 9006592 |
| Product codes | OCN, QOG |
| Device names | OCN - Insulin Autoantibody Kit, QOG - Injection Data Capture Device |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5660, 880.5860 |
| Review panels | General Hospital, Immunology |
| Registered establishments | FLEXTRONICS INTERNATIONAL GMBH |
| Establishment registrations | 3006126537 |
| FEI numbers | 3006126537 |
| 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