FDA Registration
Active
🇺🇸 United States
Professional Defibrillator AME-2900
Reg #: 3006791146
·
FEI: 3006791146
·
Expires 2025
Products
8
Proprietary Names
2
Establishment Types
1
Classifications
8
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
- K063510
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 |
|---|---|---|---|---|---|
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2023-12-28 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2023-12-28 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2023-12-28 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-12-28 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2023-12-28 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2023-12-28 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-12-28 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-12-28 |
Proprietary Names
Professional Defibrillator AME-2900
Professional Defibrillator AME-3500
Establishment Types
Repack or Relabel Medical Device