FDA device listing
900ICON203 InfoUSB2,INFOUSB_2 InfoUSB2,INFOUSB_MAC InfoUSB2,INFOUSB_METRO InfoUSB,InfoUSB software,myAirvo 3 InfoUSB
FDA device listing 1853974869 · FISHER & PAYKEL HEALTHCARE NZ LTD
Key facts
| Proprietary names | 900ICON203 InfoUSB2,INFOUSB_2 InfoUSB2,INFOUSB_MAC InfoUSB2,INFOUSB_METRO InfoUSB,InfoUSB software,myAirvo 3 InfoUSB |
|---|---|
| Owner/operator | FISHER & PAYKEL HEALTHCARE NZ LTD |
| Owner/operator number | 8040217 |
| Product codes | OUG |
| Device names | OUG - Medical Device Data System |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6310 |
| Review panels | General Hospital |
| Registered establishments | FISHER & PAYKEL HEALTHCARE, INC., FISHER & PAYKEL HEALTHCARE, LTD. |
| Establishment registrations | 2085602, 9611451 |
| FEI numbers | 3000210616, 3002806988 |
| Establishment operations | Complaint File Establishment, 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