FDA device listing
Airway, Adult Pediatric, Zoll LoFlo, 10,Airway, DEHUM TBG, ADU PED Zoll LoFlo 10,Airway, DEHUM TBG, PED INF Zoll…
FDA device listing 1345037665 · Philips Medical Systems International BV
Key facts
| Proprietary names | Airway, Adult Pediatric, Zoll LoFlo, 10,Airway, DEHUM TBG, ADU PED Zoll LoFlo 10,Airway, DEHUM TBG, PED INF Zoll LoFlo10,Airway, Pediatric Infant, Zoll LoFlo, 10,Cannula, 02 CO2 Oral, ADU, Zoll LoFlo 10,Cannula, CO2, ADU, Zoll LoFlo, 10,Cannula, CO2, INF, Zoll LoFlo, 10,Cannula, CO2 ORAL, ADU, Zoll LoFlo, 10,Cannula, CO2 Oral, PED, Zoll LoFlo, 10,Cannula, CO2, PED, Zoll LoFlo, 10,Cannula, O2 CO2… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K162832 |
| Product codes | CBK, DQA |
| Device names | CBK - Ventilator, Continuous, Facility Use, DQA - Oximeter |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5895, 870.2700 |
| Review panels | Anesthesiology, Cardiovascular |
| Registered establishments | Philips Electronics Ltd, Philips North America LLC, RESPIRONICS NOVAMETRIX, LLC |
| Establishment registrations | 1219324, 3000126629, 3016618143 |
| FEI numbers | 1219324, 3000126629, 3016618143 |
| Establishment operations | Complaint File Establishment, 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