Lifepak 12
FDA 510(k) K040775 · Medtronic Physio-Control Corp.
510(k) numberK040775
Submission
- Device name
- Lifepak 12
- Applicant
- Medtronic Physio-Control Corp.
Redmond, WA, US - Received
- March 26, 2004
- Decision date
- April 23, 2004
- 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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More from Leonhard Lang GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K033275 | Lifepak 12, 20, 500, CR PlusMKJ · Special | 11/06/2003SE |
| K022732 | Infant/Child Reduced Energy ElectrodesMKJ · Traditional | 12/13/2002SE |
| K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerLDD · Traditional | 02/05/2002SE |
| K011144 | Lifepak 600 Automated External DefibrillatorMKJ · Traditional | 12/03/2001SE |
| K012428 | Modification to: Lifepak 500 Automated External DefibrillatorMKJ · Special | 09/28/2001SE |
| K010918 | Lifepak 12 Defibrillator/Monitor SystemMKJ · Traditional | 08/23/2001ST |
| K002445 | Lifepak 12DEFIBERLLATOR/MONITOR SeriesMKJ · Traditional | 01/31/2001ST |
Questions and answers
When was Lifepak 12 cleared by the FDA?
Lifepak 12 (K040775) received a 510(k) decision of Substantially Equivalent on April 23, 2004, 28 days after the submission was received.
What is the product code of K040775?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.