FDA device listing
867184 PHILIPS Masimo O3 Module,867185 PHILIPS Masimo CO2 Module,867186 PHILIPS Masimo SedLine Module,989803203021…
FDA device listing 1304655094 · Philips Medical Systems International BV
Key facts
| Proprietary names | 867184 PHILIPS Masimo O3 Module,867185 PHILIPS Masimo CO2 Module,867186 PHILIPS Masimo SedLine Module,989803203021 Masimo O3 Measurement Device,989803203031 ISA CO2 Measurement Device,989803203041 IRMA CO2 Measurement Device,989803203051 SedLine Measurement Device |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K221348 |
| 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 Medizin Systeme Boeblingen GmbH |
| Establishment registrations | 9610816 |
| FEI numbers | 3002807167 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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