AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)

FDA Premarket Approval P190013

Pre-market Approval Supplement Details

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.

DeviceAED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantAED Battery Exchange, LLC
Date Received2019-04-29
Decision Date2021-02-02
PMAP190013
SupplementS
Product CodeMKJ 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address AED Battery Exchange, LLC 1000 Brown Street, Suite #206 wauconda, IL 60084

Supplemental Filings

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Supplement NumberDateSupplement Type
P190013Original Filing

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