FDA Registration
Active
🇲🇽 Mexico
RD SET Neo
Reg #: 3016674095
·
FEI: 3016674095
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
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
- K191059
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 |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-05-14 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2021-05-14 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2021-05-14 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2021-05-14 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2021-05-14 |
| Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | JKS | Class 1 | Clinical Toxicology | No | 2021-05-14 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-05-14 |
Proprietary Names
RD SET Neo
Establishment Types
Manufacture Medical Device