FDA Registration
Active
🇺🇸 United States
SpO2 MasimoSet Pod Set
Reg #: 3005783425
·
FEI: 3005783425
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DRAEGER MEDICAL SYSTEMS, INC.
- Registration Number
- 3005783425
- FEI Number
- 3005783425
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6 TECH DRIVE
- City
- ANDOVER
- State
- MA
- ZIP
- 01810
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061329
Owner / Operator
- Firm Name
- Draeger Medical Systems, Inc.
- Operator Number
- 9070398
- Address
- 6 Tech Drive
- City
- Andover
- State
- MA
- Postal Code
- 01810
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2006-11-07 |
Proprietary Names
SpO2 MasimoSet Pod Set
Kit SpO2 Masimo Pod
Infinity Masimo SpO2 SmartPod
Establishment Types
Manufacture Medical Device