FDA Registration
Active
🇲🇽 Mexico
Radius VSM RAS-45
Reg #: 3016674095
·
FEI: 3016674095
·
Expires 2025
Products
13
Proprietary Names
2
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- Industrial Vallera de Mexicali, S.A. de C.V. (Terra)
- Registration Number
- 3016674095
- FEI Number
- 3016674095
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Carretera Mexicali-Algodones # 4798 Int. 4-1, Col. Diez Division Dos
- City
- Mexicali Baja California
- Country
- MX
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
US Agent
- Business Name
- Masimo Corporation
- Contact Name
- Mathew Jimenez
- Address
- 52 Discovery
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 2977558
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
Manufacture Medical Device