Modification to: Lifepak 500 Automated External Defibrillator
FDA 510(k) K012428 · Medtronic Physio-Control Corp.
Submission
- Device name
- Modification to: Lifepak 500 Automated External Defibrillator
- Applicant
- Medtronic Physio-Control Corp.
Redmond, WA, US - Received
- July 31, 2001
- Decision date
- September 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K040775 | Lifepak 12MKJ · Special | 04/23/2004SE |
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| K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerLDD · Traditional | 02/05/2002SE |
| K011144 | Lifepak 600 Automated External DefibrillatorMKJ · Traditional | 12/03/2001SE |
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Questions and answers
When was Modification to: Lifepak 500 Automated External Defibrillator cleared by the FDA?
Modification to: Lifepak 500 Automated External Defibrillator (K012428) received a 510(k) decision of Substantially Equivalent on September 28, 2001, 59 days after the submission was received.
What is the product code of K012428?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.