FDA Registration
Active
🇺🇸 United States
Radius VSM RAS-45
Reg #: 3009831876
·
FEI: 3009831876
·
Expires 2025
Products
13
Proprietary Names
2
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- MASIMO CORPORATION
- Registration Number
- 3009831876
- FEI Number
- 3009831876
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9600 Jeronimo
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223498
Owner / Operator
- Firm Name
- MASIMO CORPORATION
- Operator Number
- 9031881
- Address
- 52 Discovery, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Mathew Jimenez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2023-06-05 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2023-06-05 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-06-05 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2023-06-05 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2023-06-05 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2023-06-05 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-06-05 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2023-06-05 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2023-06-05 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-06-05 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2023-06-05 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2023-06-05 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2023-06-05 |
Proprietary Names
Radius VSM RAS-45
Radius VSM and Accessories
Establishment Types
Repack or Relabel Medical Device