PMA P170018S002

Device
LIFEPAK® CR2 Defibrillator
Applicant
Physio-Control, Inc.
PMA number
P170018
Supplement
S002
Product code
MKJ
Decision date
2019-02-19
Classification
Automated External Defibrillators (non-wearable)
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval for software updates related to device readiness and cellular AED event transmissions.

Current openFDA PMA Record#

Device
LIFEPAK® CR2 Defibrillator
Applicant
Physio-Control, Inc.
PMA number
P170018
Supplement
S002
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2019-02-19
Decision code
APPR
Date received
2019-01-11
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software updates related to device readiness and cellular AED event transmissions.