PMA P160022S024

Device
R Series Device
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S024
Product code
MKJ
Decision date
2021-01-05
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Addition of a selective soldering machine used during printed circuit board assembly (PCBA) manufacturing.

Current openFDA PMA Record#

Device
R Series Device
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S024
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2021-01-05
Decision code
OK30
Date received
2020-12-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a selective soldering machine used during printed circuit board assembly (PCBA) manufacturing.