FDA Registration
Active
🇺🇸 United States
INFINITY OMEGA SOLUTION
Reg #: 3005783425
·
FEI: 3005783425
·
Expires 2025
Products
1
Proprietary Names
5
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
- K141756
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 |
|---|---|---|---|---|---|
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2015-10-26 |
Proprietary Names
INFINITY OMEGA SOLUTION
INFINITY EXPLORER
INFINITY EXPLORER MONITOR
INFINITY OMEGA MONITOR
INFINITY OMEGA S SOLUTION
Establishment Types
Manufacture Medical Device