PMA P160026S004

Device
LIFEPAK 15 monitor/defibrillator
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S004
Product code
MKJ
Decision date
2019-03-24
Classification
Automated External Defibrillators (non-wearable)
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval for a memory chip component replacement.

Current openFDA PMA Record#

Device
LIFEPAK 15 monitor/defibrillator
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S004
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2019-03-24
Decision code
APPR
Date received
2018-12-26
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a memory chip component replacement.