PMA P160032S010

Device: Defibtech Automated External Defibrillator (AED) Systems
Applicant: Defibtech, LLC
PMA number: P160032
Supplement: S010
Product code: MKJ
Decision date: 2021-09-10
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: Approval for hardware design changes to the DDU-100 Series LV board component & HV board component DDU-2000 Series Main board component as a result of field actions.

Current openFDA PMA Record#

Device: Defibtech Automated External Defibrillator (AED) Systems
Applicant: Defibtech, LLC
PMA number: P160032
Supplement: S010
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2021-09-10
Decision code: APPR
Date received: 2021-06-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for hardware design changes to the DDU-100 Series LV board component & HV board component DDU-2000 Series Main board component as a result of field actions.