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 onsite/home, models m5066a, m5067a, m5068a, and the frx, model 861304. The fr3-abe is indicated for use with the philips heartstart fr3, models 861388 and 861389.
| Device | 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 |
| PMA | P190013 |
| Supplement | S |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AED Battery Exchange, LLC 1000 Brown Street, Suite #206 wauconda, IL 60084 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P190013 | | Original Filing |
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NIH GUDID Devices