FDA device listing
CBK Series, KSR Series, RKK Series
FDA device listing 1711078510 · Epsilon Elektronik Sanayi ve Tic A.S
Key facts
| Proprietary names | CBK Series, KSR Series, RKK Series |
|---|---|
| Owner/operator | Epsilon Elektronik Sanayi ve Tic A.S |
| Owner/operator number | 10086758 |
| Product codes | IXD |
| Device names | IXD - Source, Calibration, Sealed, Nuclear |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.1400 |
| Review panels | Radiology |
| Registered establishments | Epsilon Elektronik Sanayi ve Ticaret AS |
| Establishment registrations | 3010244786 |
| FEI numbers | 3010244786 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, 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