FDA device listing
DreamStation BiPAP Auto w/ & w/o Humidifier,DreamStation BiPAP Pro w/ & w/o Humidifier,DreamStation CPAP…
FDA device listing 1143798291 · Philips Medical Systems International BV
Key facts
| Proprietary names | DreamStation BiPAP Auto w/ & w/o Humidifier,DreamStation BiPAP Pro w/ & w/o Humidifier,DreamStation CPAP Assist,Dreamstation CPAP Auto w/ & w/o Humidifier,Dreamstation CPAP Pro w/ & w/o Humidifier,DreamStation CPAP w/ & w/o Humidifier,DreamStation Go Auto CPAP,DreamStation Go CPAP,Dreamstation GO w/ & w/o Humidifier,REMstar Auto A-flex HT (Q-series) |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 2518422 |
| Premarket submissions | K131982 |
| Product codes | BZD |
| Device names | BZD - Ventilator, Non-Continuous (Respirator) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5905 |
| Review panels | Anesthesiology |
| Registered establishments | Philips Global Business Services LLP, Respironics Deutschland GmbH & Co.KG, RESPIRONICS INC., RESPIRONICS, INC. |
| Establishment registrations | 2518422, 3001400310, 3002797442, 3007220521, 3029227324 |
| FEI numbers | 2518422, 3001400310, 3002797442, 3007220521, 3029227324 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, 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