PMA P160015S013

Device
AED Plus
Applicant
ZOLL Medical Corporation
PMA number
P160015
Supplement
S013
Product code
MKJ
Decision date
2022-03-01
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Update the sequence and fully automate a shock test.

Current openFDA PMA Record#

Device
AED Plus
Applicant
ZOLL Medical Corporation
PMA number
P160015
Supplement
S013
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2022-03-01
Decision code
OK30
Date received
2022-02-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update the sequence and fully automate a shock test.