FDA Registration
Active
🇺🇸 United States
Alaris/Medley SpO2 Module
Reg #: 2016493
·
FEI: 2016493
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CareFusion 303, INC.
- Registration Number
- 2016493
- FEI Number
- 2016493
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 10020 Pacific Mesa Blvd
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K022677
Owner / Operator
- Firm Name
- CAREFUSION 303, INC.
- Operator Number
- 9068764
- Address
- 10020 Pacific Mesa Blvd., --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2008-10-16 |
Proprietary Names
Alaris/Medley SpO2 Module
Establishment Types
Complaint File Establishment per 21 CFR 820.198