FDA Registration
Active
🇺🇸 United States
Multiparameter patient monitor LM-8, LM-10, LM-12, LM-15
Reg #: 3021559257
·
FEI: 3021559257
·
Expires 2025
Products
21
Proprietary Names
1
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- CAF MEDICAL SOLUTIONS INC
- Registration Number
- 3021559257
- FEI Number
- 3021559257
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17539 Roberts Road
- City
- Hockley
- State
- TX
- ZIP
- 77447
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221879
Owner / Operator
- Firm Name
- CAF Medical Solutions Inc
- Operator Number
- 10084159
- Address
- 17539 Roberts Road
- City
- Hockley
- State
- TX
- Postal Code
- 77447
- Country
- US
- Correspondent
- Oscar Arriaga
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2022-09-02 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-09-02 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2022-09-02 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-09-02 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2022-09-02 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2022-09-02 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2022-09-02 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2022-09-02 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-09-02 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2022-09-02 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-09-02 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2022-09-02 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2022-09-02 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2022-09-02 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2022-09-02 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2022-09-02 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2022-09-02 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2022-09-02 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2022-09-02 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2022-09-02 |
| Clip, Vena-Cava | DST | Class 2 | Cardiovascular | No | 2022-09-02 |
Proprietary Names
Multiparameter patient monitor LM-8, LM-10, LM-12, LM-15
Establishment Types
Manufacture Medical Device