FDA device listing
IntelliVue Patient Monitor 6100,IntelliVue Patient Monitor 6300,IntelliVue Patient Monitor 6500
FDA device listing 1501544618 · Philips Medical Systems International BV
Key facts
| Proprietary names | IntelliVue Patient Monitor 6100,IntelliVue Patient Monitor 6300,IntelliVue Patient Monitor 6500 |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K250453 |
| Product codes | BZQ, CCK, DPS, DQA, DRT, DSF, DSJ, DSK, DXN, FLL, MHX, MLD and 1 more |
| Device names | BZQ - Monitor, Breathing Frequency, CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, DPS - Electrocardiograph, DQA - Oximeter, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSF - Recorder, Paper Chart, DSJ - Alarm, Blood-Pressure, DSK - Computer, Blood-Pressure, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), MLD - Monitor, St Segment With Alarm and 1 more |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 868.1400, 868.2375, 870.1025, 870.1100, 870.1110, 870.1130, 870.2300, 870.2340, 870.2700, 870.2810, 880.2910 |
| Review panels | Anesthesiology, Cardiovascular, General Hospital |
| Registered establishments | Philips Medical Systems Ltda, Philips Medizin Systeme Boeblingen GmbH |
| Establishment registrations | 9610816, 3014541700 |
| FEI numbers | 3002807167, 3014541700 |
| 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