PMA P160022S004

Device
Zoll X Series Device (Oridion MicroMediCO2)
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S004
Product code
MKJ
Decision date
2018-10-26
Classification
Automated External Defibrillators (non-wearable)
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval for minor changes made within the C02 module that is incorporated into ZOLL's X Series device.

Current openFDA PMA Record#

Device
Zoll X Series Device (Oridion MicroMediCO2)
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S004
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2018-10-26
Decision code
APPR
Date received
2018-05-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor changes made within the C02 module that is incorporated into ZOLL's X Series device.