Automated External Defibrillators (Non-Wearable)
Basic Information
- Device Name
- Automated External Defibrillators (Non-Wearable)
- Trade Name
- LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger
- PMA Number
- P160012
- Device Class
- FDA Class 3
- Product Code
- MKJ
- Generic Name
- Automated external defibrillators (non-wearable)
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 21, 2017
- Date Received
- April 27, 2016
- Expedited Review
- N
- Docket Number
- 17M-6983
Advisory Committee Statement
Approval for the LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger. The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement).The devices are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program.The defibrillators may be used with QUIK-PAK defibrillations pads only on adults and children who are 8 years old or more, or who weigh more than 25kg (55lbs). The defibrillators may be used on children who are less than 8 years old or weigh less than 25k (55lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.The defibrillators may be used with the CHARGE-PAK battery charger.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | Cardiovascular |