DBP-1400-ABE and DBP-2003- ABE
FDA premarket approval P190013/S001 · decided 2025-10-28
Approval details
- PMA number
- P190013
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DBP-1400-ABE and DBP-2003- ABE
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Aed Battery Exchange, LLC
- Date received
- 2025-04-03
- Decision date
- 2025-10-28
- Days to decision
- 208 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Wauconda, IL
- Statement
- approval for two new models of re-celled automated external defibrillator (AED) batteries, models DBP-1400-ABE and DBP-2003-ABE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EXTENDED LIFE BATTERY (K120350) | Aed Battery Exchange, LLC | 2012-11-01 |