Semiautomatic External Defibrillator and Accessories
FDA 510(k) K131525 · Defibtech, LLC
Submission
- Device name
- Semiautomatic External Defibrillator and Accessories
- Applicant
- Defibtech, LLC
Guilford, CT, US - Received
- May 28, 2013
- Decision date
- April 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5310
- Specialty
- Cardiovascular
This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is…
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| K121853 | DDU-2400/2450 Semiautomatic External Defibrillator and AccessoriesMKJ · Traditional | 12/13/2012SE |
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| K033144 | Defibtech Electrode Adapter, Model DAC-300 SeriesMKJ · Traditional | 11/13/2003SE |
| K013896 | Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes)…MKJ · Traditional | 06/19/2002ST |
Questions and answers
When was Semiautomatic External Defibrillator and Accessories cleared by the FDA?
Semiautomatic External Defibrillator and Accessories (K131525) received a 510(k) decision of Substantially Equivalent on April 24, 2014, 331 days after the submission was received.
What is the product code of K131525?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.