FDA device listing
RT047XS/S/M/L,RT057XS/S/M/L
FDA device listing 1359833566 · FISHER & PAYKEL HEALTHCARE NZ LTD
Key facts
| Proprietary names | RT047XS/S/M/L,RT057XS/S/M/L |
|---|---|
| Owner/operator | FISHER & PAYKEL HEALTHCARE NZ LTD |
| Owner/operator number | 8040217 |
| Premarket submissions | K191624 |
| Product codes | MNT |
| Device names | MNT - Continuous, Minimal Ventilatory Support, Facility Use Ventilator |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5895 |
| Review panels | Anesthesiology |
| Registered establishments | FISHER & PAYKEL HEALTHCARE, INC., FISHER & PAYKEL HEALTHCARE, LTD., Fisher & Paykel Healthcare S.A.de C.V. |
| Establishment registrations | 2085602, 9611451, 3008264065 |
| FEI numbers | 3000210616, 3002806988, 3008264065 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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