FDA Registration
Active
🇺🇸 United States
AWARE
Reg #: 3010692333
·
FEI: 3010692333
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ambient Clinical Analytics
- Registration Number
- 3010692333
- FEI Number
- 3010692333
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 221 1st Avenue Southwest, #202
- City
- Rochester
- State
- MN
- ZIP
- 55902
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143372
Owner / Operator
- Firm Name
- Ambient Clinical Analytics
- Operator Number
- 10049034
- Address
- 221 1st Avenue Southwest #202
- City
- Rochester
- State
- MN
- Postal Code
- 55902
- Country
- US
- Correspondent
- Allen Berning
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2015-04-03 |
Proprietary Names
AWARE
Establishment Types
Manufacture Medical Device