PMA P160022S023

Device
X Series, R Series, and AED Pro
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S023
Product code
MKJ
Decision date
2020-12-07
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
new equipment used in the flex printed circuit board manufacturing line at a supplier

Current openFDA PMA Record#

Device
X Series, R Series, and AED Pro
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S023
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2020-12-07
Decision code
OK30
Date received
2020-11-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
new equipment used in the flex printed circuit board manufacturing line at a supplier