PMA P160026S023

Device
LIFEPAK Automated External Defibrillator (AED)
Applicant
Physio-Control, Inc.
Product code
MKJ
Decision date
2021-04-22
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval for minor software and labeling changes

Current openFDA PMA Record#

Device
LIFEPAK Automated External Defibrillator (AED)
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S023
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2021-04-22
Decision code
APPR
Date received
2021-01-25
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor software and labeling changes