FDA device listing
IntelliVue MX400, MX450, MX500, MX550, Rev. R
FDA device listing 1497062134 · Philips Medical Systems International BV
Key facts
| Proprietary names | IntelliVue MX400, MX450, MX500, MX550, Rev. R |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K251146 |
| Product codes | BZC, BZQ, CBQ, CBR, CBS, CCK, CCL, DPS, DQA, DQK, DRT, DSF and 15 more |
| Device names | BZC - Calculator, Pulmonary Function Data, BZQ - Monitor, Breathing Frequency, CBQ - Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration), CBR - Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), CBS - Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.), CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, CCL - Analyzer, Gas, Oxygen, Gaseous-Phase, DPS - Electrocardiograph, DQA - Oximeter, DQK - Computer, Diagnostic, Programmable, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSF - Recorder, Paper Chart and 15 more |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 868.1400, 868.1500, 868.1620, 868.1700, 868.1720, 868.1880, 868.2375, 868.2480, 868.2500, 868.2775, 870.1025, 870.1100 and 10 more |
| Review panels | Anesthesiology, Cardiovascular, General Hospital, Neurology |
| Registered establishments | Philips Medizin Systeme Boeblingen GmbH, Philips North America LLC |
| Establishment registrations | 9610816, 3016618143 |
| FEI numbers | 3002807167, 3016618143 |
| Establishment operations | Complaint File Establishment, 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