FDA.reportPublic FDA data

PMA P160026S019

Device
LIFEPAK Automated External Defibrillators (AEDs)
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S019
Product code
MKJ
Decision date
2020-06-18
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Update to software and hardware associated with the manufacturing of the Noninvasive Blood Pressure (NIBP) module, a component of the LIFEPAK 15 monitor/defibrillator.

Current openFDA PMA Record#

Device
LIFEPAK Automated External Defibrillators (AEDs)
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S019
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2020-06-18
Decision code
OK30
Date received
2020-05-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update to software and hardware associated with the manufacturing of the Noninvasive Blood Pressure (NIBP) module, a component of the LIFEPAK 15 monitor/defibrillator.