PMA P160033S008

Device
Powerheart G5 AED
Applicant
ZOLL Medical Corporation
PMA number
P160033
Supplement
S008
Product code
MKJ
Decision date
2021-06-14
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Add a supplier for the AED main PCBA.

Current openFDA PMA Record#

Device
Powerheart G5 AED
Applicant
ZOLL Medical Corporation
PMA number
P160033
Supplement
S008
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2021-06-14
Decision code
OK30
Date received
2021-06-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add a supplier for the AED main PCBA.