FDA Registration
Active
🇺🇸 United States
Radius-7
Reg #: 3019388613
·
FEI: 3019388613
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Masimo Corporation
- Registration Number
- 3019388613
- FEI Number
- 3019388613
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15750 Alton Parkway
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193242
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 |
|---|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2021-03-09 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-03-09 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2021-03-09 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2021-03-09 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2021-03-09 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2021-03-09 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-03-09 |
| Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | JKS | Class 1 | Clinical Toxicology | No | 2021-03-09 |
Proprietary Names
Radius-7
Establishment Types
Complaint File Establishment per 21 CFR 820.198