FDA Registration
Active
🇺🇸 United States
RD SedLine Sensors
Reg #: 3019388613
·
FEI: 3019388613
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
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
- K203113
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 |
|---|---|---|---|---|---|
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2022-03-22 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2022-03-22 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-03-22 |
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2022-03-22 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2022-03-22 |
Proprietary Names
RD SedLine Sensors
SedLine Sensors
SedLine Module
Establishment Types
Complaint File Establishment per 21 CFR 820.198