- Device
- Defibtech Automated External Defibrillator (AED) Systems
- Applicant
- Defibtech, LLC
- PMA number
- P160032
- Supplement
- S008
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-10-16
- Decision code
- APPR
- Date received
- 2020-07-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for circuit board design changes necessary to replace obsolete flash components in Defibtech DDU-100 series Automated External Defibrillator (AED) Systems