FDA Registration
Active
🇺🇸 United States
DDU-1000 Semiautomatic External Defibrillator and Accessories
Reg #: 3012972516
·
FEI: 3012972516
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Defibtech Branford
- Registration Number
- 3012972516
- FEI Number
- 3012972516
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14 Commercial St
- City
- Branford
- State
- CT
- ZIP
- 06405
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131525
Owner / Operator
- Firm Name
- DEFIBTECH, LLC
- Operator Number
- 9048526
- Address
- 741 BOSTON POST ROAD, SUITE 201
- City
- Guilford
- State
- CT
- Postal Code
- 06437
- Country
- US
- Correspondent
- Robert Jamieson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2014-10-30 |
Proprietary Names
DDU-1000 Semiautomatic External Defibrillator and Accessories
Lifeline 2 Semiautomatic External Defibrillator and Accessories
Establishment Types
Manufacture Medical Device