FDA Registration
Active
🇺🇸 United States
DYMEDIX DIAGNOSTICS INC
Reg #: 3009351773
·
FEI: 3009351773
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- DYMEDIX DIAGNOSTICS INC
- Registration Number
- 3009351773
- FEI Number
- 3009351773
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5985 Rice Creek Pkwy Ste 102
- City
- Shoreview
- State
- MN
- ZIP
- 55126
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192564
Owner / Operator
- Firm Name
- Dymedix Diagnostics Inc
- Operator Number
- 10039354
- Address
- 5985 Rice Creek Parkway, Suite 102
- City
- Shoreview
- State
- MN
- Postal Code
- 55126
- Country
- US
- Correspondent
- Brad Dawson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2022-12-01 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2023-12-08 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2011-12-30 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2011-12-30 |
Proprietary Names
FlexPro Biopotential Electrodes
Disposable Gold Cup EEG Electrodes
Monitor, breathing frequency
Ventilatory Effort Recorder
Monitor breathing frequency
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility