PMA P160026S037

Device
LIFEPAK Automated External Defibrillators (AEDs)
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S037
Product code
MKJ
Decision date
2023-01-04
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Manufacturing site location change for the inductive resistor component.

Current openFDA PMA Record#

Device
LIFEPAK Automated External Defibrillators (AEDs)
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S037
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2023-01-04
Decision code
OK30
Date received
2022-12-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing site location change for the inductive resistor component.