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510(k) Data Aggregation
(320 days)
The Metron U.S. OA-40M Defibrillator Analyzer is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with the specified requirements.
The QA-40M tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load and can also provide waveform information. The OA-40M test for ANSI/AAMI DF39 standards.
The QA-40M Defibrillator Analyzer's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohm, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the OA-40M contact plates. Thus, the defibrillator is connected through load resistance, When the defibrillator is discharged. OA-40M will calculate and display the energy delivered.
The OA-40M Defibrillator Analyzer performs the following tests and features (1) energy and cardioversion measurement, (2) peak voltage and current reading, (3) storage and playback of output waveform. (4) 12 lead ECG simulation. (5) ECG, performance and arrhythmia simulation, (6) transcutaneous cardiac pacemaker testing ( module is optional), (7) integrated pacemaker loads selectable from 50 ohm to 2500 ohm, (8) automatic defibrillator test procedures, (9) large graphic display and (10) RS-232C and Centronic printer interface.
The QA-40M tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load and can also provide waveform information. The OA-40M test for ANSI/AAMI DF39 standards.
The QA-40M Defibrillator Analyzer's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohm, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the OA-40M contact plates. Thus, the defibrillator is connected through load resistance, When the defibrillator is discharged. OA-40M will calculate and display the energy delivered.
The OA-40M Defibrillator Analyzer performs the following tests and features (1) energy and cardioversion measurement, (2) peak voltage and current reading, (3) storage and playback of output waveform. (4) 12 lead ECG simulation. (5) ECG, performance and arrhythmia simulation, (6) transcutaneous cardiac pacemaker testing ( module is optional), (7) integrated pacemaker loads selectable from 50 ohm to 2500 ohm, (8) automatic defibrillator test procedures, (9) large graphic display and (10) RS-232C and Centronic printer interface.
The provided text is a 510(k) premarket notification approval letter for a medical device called the "Metron U.S. QA-40M Defibrillator Analyzer." However, this document does not contain the detailed information necessary to complete the requested table and study description.
Specifically, it is an approval letter stating that the device is "substantially equivalent" to previously marketed devices. It describes the device's indications for use and functions, but it does not include any acceptance criteria, performance data, or details of a study that proves the device meets specific criteria.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study based on the provided text. The document itself is the FDA's response to a submission, not the submission or study report itself.
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