PMA P190013S001
- Device
- DBP-1400-ABE and DBP-2003- ABE
- Applicant
- Aed Battery Exchange, LLC
- PMA number
- P190013
- Supplement
- S001
- Product code
- MKJ
- Decision date
- 2025-10-28
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- approval for two new models of re-celled automated external defibrillator (AED) batteries, models DBP-1400-ABE and DBP-2003-ABE.
Current openFDA PMA Record#
- Device
- DBP-1400-ABE and DBP-2003- ABE
- Applicant
- Aed Battery Exchange, LLC
- PMA number
- P190013
- Supplement
- S001
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-10-28
- Decision code
- APPR
- Date received
- 2025-04-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for two new models of re-celled automated external defibrillator (AED) batteries, models DBP-1400-ABE and DBP-2003-ABE.