PMA P160015S007

Device
Zoll AED 3
Applicant
ZOLL Medical Corporation
PMA number
P160015
Supplement
S007
Product code
MKJ
Decision date
2020-12-21
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
approval to use Fluke Impulse 6000/7000 Defibrillator Analyzers for defibrillation energy testing

Current openFDA PMA Record#

Device
Zoll AED 3
Applicant
ZOLL Medical Corporation
PMA number
P160015
Supplement
S007
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2020-12-21
Decision code
OK30
Date received
2020-12-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval to use Fluke Impulse 6000/7000 Defibrillator Analyzers for defibrillation energy testing