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FDA SSED.pdf

ABE-G5-SSED.pdf
Preview of FDA SSED
🔗 Source: files.batteryjunction.com
📊 Size: 66 KB
👤 Author: Deoras, Aneesh
⬇️ Downloads: 145

Summary

The FDA has approved the AED Battery Exchange models 9146-ABE, G5-ABE, 5070-ABE, and FR3-ABE, which are primary batteries for automated external defibrillators (AEDs). The devices provide power to AEDs during self-maintenance, automated diagnoses, and defibrillation. They are indicated for use with specific Cardiac Science and Philips AED models. The approval is based on a combination of literature review and in-vitro bench testing, which demonstrated a reasonable assurance of safety and effectiveness. Potential adverse effects associated with the use of the device include failure to identify shockable arrhythmia, failure to deliver a defibrillation shock, and electromagnetic interference. Non-clinical studies, including bench testing, were conducted to verify the safety and effectiveness of the devices.

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Description

The FDA has approved the AED Battery Exchange models 9146-ABE, G5-ABE, 5070-ABE, and FR3-ABE, which are primary batteries for automated external defibrillators...

Technical Information

  • File Format: PDF
  • File Size: 66 KB
  • Pages: 9
  • Language: EN
  • Author: Deoras, Aneesh
  • Total Downloads: 145
  • Last Updated: 6 days ago

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