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Device | AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | AED Battery Exchange, LLC 1000 Brown Street, Suite #206 Wauconda, IL 60084 |
PMA Number | P190013 |
Date Received | 04/29/2019 |
Decision Date | 02/02/2021 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
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