FDA device listing
C2000-E208,C2000-E480,C2000L-E208,C2000L-E480,C2000L-S208,C2000L-S480,C2000LW-E208,C2000LW-E480,C2000LW-S208,C2000LW-S48…
FDA device listing 1447860518 · Skytron, LLC
Key facts
| Proprietary names | C2000-E208,C2000-E480,C2000L-E208,C2000L-E480,C2000L-S208,C2000L-S480,C2000LW-E208,C2000LW-E480,C2000LW-S208,C2000LW-S480,C2000-S208,C2000-S480,C2000W-E208,C2000W-E480,C2000W-S208,C2000W-S480,CleanStart,Flex Surgical Instrument Washer,Skytron I3; Skytron I5; Sterling Washer P1500, P1000, P1800,Sterling C2000 Series Cart Washer |
|---|---|
| Owner/operator | Skytron, LLC |
| Owner/operator number | 9918015 |
| Product codes | MEC |
| Device names | MEC - Disinfector, Medical Devices |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6992 |
| Review panels | General Hospital |
| Registered establishments | Skytron, LLC |
| Establishment registrations | 1825014 |
| FEI numbers | 1825014 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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