PMA P160026S015

Device
LIFEPAK Automated External Defibrillators (AEDs)
Applicant
Physio-Control, Inc.
Product code
MKJ
Decision date
2021-07-08
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval for the Infant/Child Reduced Energy Defibrillation Electrodes for use with the LIFEPAK 1000, LIFEPAK CR Plus, and LIFEPAK EXPRESS defibrillators.

Current openFDA PMA Record#

Device
LIFEPAK Automated External Defibrillators (AEDs)
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S015
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2021-07-08
Decision code
APPR
Date received
2020-01-30
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the Infant/Child Reduced Energy Defibrillation Electrodes for use with the LIFEPAK 1000, LIFEPAK CR Plus, and LIFEPAK EXPRESS defibrillators.