FDA device listing
Gaush corneal confocal microscope,Heidelberg RCM
FDA device listing 1319821210 · Gaush Neotech Ltd.
Key facts
| Proprietary names | Gaush corneal confocal microscope,Heidelberg RCM |
|---|---|
| Owner/operator | Gaush Neotech Ltd. |
| Owner/operator number | 10096240 |
| Product codes | PUE |
| Device names | PUE - Biomicroscope, Slit-Lamp, Ac-Powered, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.1850 |
| Review panels | Ophthalmic |
| Registered establishments | GAUSH NEOTECH LTD. |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- None 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