FDA device listing
Greenfield,HRIM,Insight G2,Insight G3,InSight Ultima,PriZm,Sensor PAC,Viscous Swallow Challenge,ZepHr,ZVU
FDA device listing 1622113643 · DIVERSATEK HEALTHCARE
Key facts
| Proprietary names | Greenfield,HRIM,Insight G2,Insight G3,InSight Ultima,PriZm,Sensor PAC,Viscous Swallow Challenge,ZepHr,ZVU |
|---|---|
| Owner/operator | DIVERSATEK HEALTHCARE |
| Owner/operator number | 2023374 |
| Premarket submissions | K012232 |
| Product codes | FFX |
| Device names | FFX - System, Gastrointestinal Motility (Electrical) |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1725 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | DIVERSATEK HEALTHCARE INC. |
| Establishment registrations | 2023374 |
| FEI numbers | 2023374 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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