PMA P160022S005

Device
Zoll X Series Device
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S005
Product code
MKJ
Decision date
2018-08-03
Classification
Automated External Defibrillators (non-wearable)
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval for introducing the following three new software features to the ZOLL X Series device: readiness test, AutoPulse recognition, and ResQPUMP recognition.

Current openFDA PMA Record#

Device
Zoll X Series Device
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S005
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2018-08-03
Decision code
APPR
Date received
2018-06-07
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for introducing the following three new software features to the ZOLL X Series device: readiness test, AutoPulse recognition, and ResQPUMP recognition.