PMA P160032S001
- Device
- Defibtech Automated External Defibrillator (AED) Systems
- Applicant
- Defibtech, LLC
- PMA number
- P160032
- Supplement
- S001
- Product code
- MKJ
- Decision date
- 2018-12-06
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Change to the manufacturing test limit acceptance criteria on two test stations (Base Functional Test and System Functional Test) for the Defibtech DDU-100 series and DDU-2000 series AEDs.
Current openFDA PMA Record#
- Device
- Defibtech Automated External Defibrillator (AED) Systems
- Applicant
- Defibtech, LLC
- PMA number
- P160032
- Supplement
- S001
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2018-12-06
- Decision code
- OK30
- Date received
- 2018-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the manufacturing test limit acceptance criteria on two test stations (Base Functional Test and System Functional Test) for the Defibtech DDU-100 series and DDU-2000 series AEDs.