FDA Registration
Active
🇺🇸 United States
NomoLine ISA OR+
Reg #: 3011353843
·
FEI: 3011353843
·
Expires 2025
Products
21
Proprietary Names
7
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- MASIMO CORPORATION
- Registration Number
- 3011353843
- FEI Number
- 3011353843
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 52 Discovery
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171121
Owner / Operator
- Firm Name
- MASIMO CORPORATION
- Operator Number
- 9031881
- Address
- 52 Discovery, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2018-05-15 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2018-05-15 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-05-15 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2018-05-15 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2018-05-15 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2018-05-15 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2018-05-15 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2018-05-15 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2018-05-15 |
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2018-05-15 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2018-05-15 |
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2018-05-15 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2018-05-15 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2018-05-15 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2018-05-15 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-05-15 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2018-05-15 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2018-05-15 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2018-05-15 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2018-05-15 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2018-05-15 |
Proprietary Names
NomoLine ISA OR+
ISA AX+ Module
NomoLine Accessories
NomoLine-O Accessories
NomoLine ISA CO2
ISA CO2 Module
NomoLine ISA AX+
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility