PMA P160015S012

Device: AED 3, AED Plus
Applicant: ZOLL Medical Corporation
PMA number: P160015
Supplement: S012
Product code: MKJ
Decision date: 2021-08-13
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: Addition of an alternate soldering machine, replacement of an existing wash machine, replacement of an existing ionograph machine, and replacement of existing IC manual programming.

Current openFDA PMA Record#

Device: AED 3, AED Plus
Applicant: ZOLL Medical Corporation
PMA number: P160015
Supplement: S012
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2021-08-13
Decision code: OK30
Date received: 2021-08-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate soldering machine, replacement of an existing wash machine, replacement of an existing ionograph machine, and replacement of existing IC manual programming.