AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)
FDA premarket approval P190013 · decided 2021-02-02
Approval details
- PMA number
- P190013
- Trade name
- AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Aed Battery Exchange, LLC
- Date received
- 2019-04-29
- Decision date
- 2021-02-02
- Days to decision
- 645 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Wauconda, IL
- Statement
- Approval for the AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE). The AED battery supplies power to an AED as required during self maintenance, automated diagnoses, and defibrillation. The 9146-ABE is indicated for use with the Cardiac Science Powerheart G3, models 9390A, 9390E, 9300A, and 9300E. The G5-ABE is indicated for use with the Cardiac Science Powerheart G5, models G5A-80A, G5A-80C, G5S-80A, and G5S-80C. The 5070-ABE is indicated for use with the Philips HeartStart OnS
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EXTENDED LIFE BATTERY (K120350) | Aed Battery Exchange, LLC | 2012-11-01 |