FDA Registration
Active
🇨🇦 Canada
IntelliVue Patient Monitor MX750 IntelliVue Patient Monitor MX850 IntelliVue 4-Slot module rack FMX-4
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
26
Proprietary Names
1
Establishment Types
1
Classifications
26
Registration Details
- Registration Name
- Philips Electronics Ltd
- Registration Number
- 3000126629
- FEI Number
- 3000126629
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1875 Buckhorn Gate, 5th Floor
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K210906
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- Philips
- Contact Name
- Shaylee Masilunas
- Address
- 6501 Living Place
- City
- Pittsburgh
- State
- PA
- ZIP
- 15206
- Country
- US
- [email protected]
- Phone
- 724 8162019
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2021-10-08 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2021-10-08 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2021-10-08 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2021-10-08 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2021-10-08 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2021-10-08 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2021-10-08 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2021-10-08 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2021-10-08 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2021-10-08 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2021-10-08 |
| Analyzer, Spectrum, Electroencephalogram Signal | GWS | Class 1 | Neurology | No | 2021-10-08 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2021-10-08 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2021-10-08 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-10-08 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2021-10-08 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2021-10-08 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2021-10-08 |
| Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK | Class 2 | Anesthesiology | No | 2021-10-08 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2021-10-08 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2021-10-08 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2021-10-08 |
| Monitor, Carbon-Dioxide, Cutaneous | LKD | Class 2 | Anesthesiology | No | 2021-10-08 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2021-10-08 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2021-10-08 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-10-08 |
Proprietary Names
IntelliVue Patient Monitor MX750 IntelliVue Patient Monitor MX850 IntelliVue 4-Slot module rack FMX-4
Establishment Types
Export Device to the United States But Perform No Other Operation on Device