FDA Registration
Active
🇺🇸 United States
Medical Monitor Vital Signs AME-M9
Reg #: 3006791146
·
FEI: 3006791146
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- AMELIFE LLC
- Registration Number
- 3006791146
- FEI Number
- 3006791146
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8 THE GRN, STE 7302
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170712
Owner / Operator
- Firm Name
- AMELIFE LLC
- Operator Number
- 10022811
- Address
- World Trade Center Delaware 802 NW St, STE 105
- City
- Wilmington
- State
- DE
- Postal Code
- 19801
- Country
- US
- Correspondent
- EZEQUIEL CRIVOLOTTI
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-12-14 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-12-14 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2020-12-14 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2020-12-14 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-12-14 |
Proprietary Names
Medical Monitor Vital Signs AME-M9
Establishment Types
Repack or Relabel Medical Device