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ZOLL First Responder Padz Adult Defibrillation Electrodes will be used for the following clinical applications:

• Defibrillation
• Electrocardiograph Monitoring
  In conjuction with these devices:
• ZOLL PD™ 1200 Pacemaker/Defibrillator
• ZOLL PD™ 1400 Pacemaker/Defibrillator
• ZOLL PD™ 2000 Pacemaker/Defibrillator
• ZOLL D 900 Defibrillator
• ZOLL D 1400 Defibrillator
• ZOLL D 2000 Defibrillator
• ZOLL 1600 Pacemaker/Defibrillator
• ZOLL 1700 Pacemaker/Defibrillator
• ZOLL 1700 Facemanen sive Temporary Pacemaker
• ZOLL M Series

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Bio-Detek Incorporated for their ZOLL First Responder Padz Adult Defibrillation Electrodes. This document primarily focuses on the regulatory approval process and the determination of substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information such as:

• Table of acceptance criteria and reported device performance
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used
• Sample size for training set
• Method for establishing ground truth for training set

This document is a regulatory approval letter, not a technical report or study summary.

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