PMA P160022S022

Device
X Series, Propaq MD, and R Series
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S022
Product code
MKJ
Decision date
2020-09-29
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Replacement of two Automated Optical Inspection (AOI) machines located at supplier facilities.

Current openFDA PMA Record#

Device
X Series, Propaq MD, and R Series
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S022
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2020-09-29
Decision code
OK30
Date received
2020-09-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of two Automated Optical Inspection (AOI) machines located at supplier facilities.