FDA device listing
867040 - IntelliVue Capnography Extension,867041 - IntelliVue Microstream Extension
FDA device listing 1152113983 · Philips Medical Systems International BV
Key facts
| Proprietary names | 867040 - IntelliVue Capnography Extension,867041 - IntelliVue Microstream Extension |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K172904 |
| Product codes | BZQ, CCK, DRQ, DSA, DXG, FLL |
| Device names | BZQ - Monitor, Breathing Frequency, CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, DRQ - Amplifier And Signal Conditioner, Transducer Signal, DSA - Cable, Transducer And Electrode, Patient, (Including Connector), DXG - Computer, Diagnostic, Pre-Programmed, Single-Function, FLL - Continuous Measurement Thermometer |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 868.2375, 870.1435, 870.2060, 870.2900, 880.2910 |
| Review panels | Anesthesiology, Cardiovascular, General Hospital |
| Registered establishments | Philips Electronics Ltd, Philips Medizin Systeme Boeblingen GmbH, Philips North America LLC |
| Establishment registrations | 9610816, 3000126629, 3012528160, 3016701404 |
| FEI numbers | 3000126629, 3002807167, 3012528160, 3016701404 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract Manufacturer, Foreign Exporter |
| 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