FDA Registration
Active
🇺🇸 United States
IRMA CO2
Reg #: 3011353843
·
FEI: 3011353843
·
Expires 2025
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
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
- K123043
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 |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-03-28 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2022-03-28 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2022-03-28 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2022-03-28 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2022-03-28 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2022-03-28 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2022-03-28 |
Proprietary Names
IRMA CO2
IRMA Airway Adapter
IRMA AX+
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility