PMA P160026S013

Device
LIFEPAK Automated External Defibrillators (AEDs)
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S013
Product code
MKJ
Decision date
2020-01-17
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval for a material change for two PCBAs in the LifePak Automated External Defibrillators (AEDs).

Current openFDA PMA Record#

Device
LIFEPAK Automated External Defibrillators (AEDs)
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S013
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2020-01-17
Decision code
APPR
Date received
2019-10-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a material change for two PCBAs in the LifePak Automated External Defibrillators (AEDs).