FDA Registration
Active
🇺🇸 United States
Omni, Omni K
Reg #: 1066427
·
FEI: 3007513035
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- INFINIUM MEDICAL, INC.
- Registration Number
- 1066427
- FEI Number
- 3007513035
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 12151 62ND ST., N,, UNIT 5
- City
- Largo
- State
- FL
- ZIP
- 33773
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112329
Owner / Operator
- Firm Name
- INFINIUM MEDICAL, INC.
- Operator Number
- 10028895
- Address
- 12151 62ND ST N, UNIT 5
- City
- Largo
- State
- FL
- Postal Code
- 33773
- Country
- US
- Correspondent
- Oz Ozkaya
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2012-07-31 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2012-07-31 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2012-07-31 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2012-07-31 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2012-07-31 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2012-07-31 |
Proprietary Names
Omni, Omni K
Establishment Types
Manufacture Medical Device