Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor
FDA 510(k) K130454 · Physio-Control, Inc.
Submission
- Device name
- Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor
- Applicant
- Physio-Control, Inc.
Redmond, WA, US - Received
- February 22, 2013
- Decision date
- August 21, 2013
- 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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| K103567 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | 03/22/2011SE |
| K102972 | Lifepak 12MKJ · Special | 12/22/2010SE |
| K102757 | Lifenet SystemMSX · Special | 11/05/2010SE |
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Questions and answers
When was Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor cleared by the FDA?
Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor (K130454) received a 510(k) decision of Substantially Equivalent on August 21, 2013, 180 days after the submission was received.
What is the product code of K130454?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.