PMA P170018S015

Device
LIFEPAK® CR2 Defibrillator
Applicant
Physio-Control, Inc.
PMA number
P170018
Supplement
S015
Product code
MKJ
Decision date
2023-01-10
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval for adding a clip over the magnetic component in the LIFEPAK CR2 defibrillator lid.

Current openFDA PMA Record#

Device
LIFEPAK® CR2 Defibrillator
Applicant
Physio-Control, Inc.
PMA number
P170018
Supplement
S015
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2023-01-10
Decision code
APPR
Date received
2022-10-13
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for adding a clip over the magnetic component in the LIFEPAK CR2 defibrillator lid.