FDA Registration
Active
🇩🇪 Germany
IntelliVue 4-Slot Module Rack FMX-4 (866468)
Reg #: 9610816
·
FEI: 3002807167
·
Expires 2025
Products
26
Proprietary Names
3
Establishment Types
3
Classifications
26
Registration Details
- Registration Name
- Philips Medizin Systeme Boeblingen GmbH
- Registration Number
- 9610816
- FEI Number
- 3002807167
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HEWLETT-PACKARD STRASSE 2
- City
- BOEBLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K231671
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
- Deborah Currlin
- Address
- 222 Jacobs Street
- City
- Cambridge
- State
- MA
- ZIP
- 02141
- Country
- US
- [email protected]
- Phone
- 858 9452753
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK | Class 2 | Anesthesiology | No | 2023-12-20 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2023-12-20 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2023-12-20 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2023-12-20 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2023-12-20 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-12-20 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2023-12-20 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2023-12-20 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2023-12-20 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2023-12-20 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2023-12-20 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2023-12-20 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2023-12-20 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2023-12-20 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2023-12-20 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-12-20 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2023-12-20 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2023-12-20 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-12-20 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-12-20 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2023-12-20 |
| Monitor, Carbon-Dioxide, Cutaneous | LKD | Class 2 | Anesthesiology | No | 2023-12-20 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2023-12-20 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2023-12-20 |
| Analyzer, Spectrum, Electroencephalogram Signal | GWS | Class 1 | Neurology | No | 2023-12-20 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2023-12-20 |
Proprietary Names
IntelliVue 4-Slot Module Rack FMX-4 (866468)
IntelliVue Patient Monitor MX850 (866470)
IntelliVue Patient Monitor MX750 (866471)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device