FDA device listing
AOM (RIMR),DreamMapper,DreamStation Cellular Modem (RIST),DreamStation Link Module (RIST),DreamStation Wi-Fi Accessory…
FDA device listing 1713899733 · Philips Medical Systems International BV
Key facts
| Proprietary names | AOM (RIMR),DreamMapper,DreamStation Cellular Modem (RIST),DreamStation Link Module (RIST),DreamStation Wi-Fi Accessory (RIST),HL7 Interface Utility (RIMR),Omnilab Conncect (RIMR),Payer Integration Software (RIMR),PR1 Wired/Wireless Modems (RIST),Sleepmapper (RIMR) |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 2518422 |
| 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 | RESPIRONICS INC., RESPIRONICS, INC. |
| Establishment registrations | 2518422, 3007220521 |
| FEI numbers | 2518422, 3007220521 |
| 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