FDA device listing
CO2 Nasal Cannula - Infant,CO2 Nasal Cannula - Pediatric,IntelliVue Patient Monitors,Philips ADU Nasal CO2 Cannula…
FDA device listing 1747224846 · Philips Medical Systems International BV
Key facts
| Proprietary names | CO2 Nasal Cannula - Infant,CO2 Nasal Cannula - Pediatric,IntelliVue Patient Monitors,Philips ADU Nasal CO2 Cannula, M2744A,Philips ADU Nasal CO2 O2 Cannula, M2750A,Philips ADU Oral Nasal CO2 Can, M2756A,Philips ADU Oral Nas CO2 O2 Can, M2760A,Philips ADU PED A ADPTR W Humid, M2772A,Philips ADU PED Airway Adapter, M2768A,Philips INF Nasal CO2 O2 Cannula,Philips PED INF A ADPTR W HUMID… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K060221 |
| Product codes | MHX |
| Device names | MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025 |
| Review panels | Cardiovascular |
| Registered establishments | Philips Electronics Ltd, Philips Medizin Systeme Boeblingen GmbH, RESPIRONICS NOVAMETRIX, LLC |
| Establishment registrations | 1219324, 9610816, 3000126629 |
| FEI numbers | 1219324, 3000126629, 3002807167 |
| Establishment operations | Complaint File Establishment, Manufacturer, Remanufacturer, Repackager/Relabeler, Foreign Exporter, Specification Developer |
| 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