PMA P160022S026

Device
ZOLL AED 3 BLS
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S026
Product code
MKJ
Decision date
2021-03-18
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Update the existing HiPot test fixture.

Current openFDA PMA Record#

Device
ZOLL AED 3 BLS
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S026
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2021-03-18
Decision code
OK30
Date received
2021-02-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update the existing HiPot test fixture.