Defibtech Automated External Defibrillator (AED) Systems
FDA premarket approval P160032/S009 · decided 2020-10-23
Approval details
- PMA number
- P160032
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Defibtech Automated External Defibrillator (AED) Systems
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Defibtech, LLC
- Date received
- 2020-07-27
- Decision date
- 2020-10-23
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Guilford, CT
- Statement
- Approval for software updates to the self-test features for the DDU-100 series AEDs.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RMU-2000 Automated Chest Compression System (K211289) | Defibtech, LLC | 2021-11-09 |
| RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (K141809) | Defibtech, LLC | 2014-10-27 |
| SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K131525) | Defibtech, LLC | 2014-04-24 |
| DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K113787) | Defibtech, LLC | 2013-01-04 |
| DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K121853) | Defibtech, LLC | 2012-12-13 |
| DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K081259) | Defibtech, LLC | 2009-06-15 |
| DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P (K033896) | Defibtech, LLC | 2004-06-16 |
| DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES (K033144) | Defibtech, LLC | 2003-11-13 |