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The MAC 600 Resting ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediatric populations. Basic systems deliver 3 or 12 lead ECGs, and can be upgraded to provide software analysis options such as interpretive analysis of the electrocardiogram. Transmission of ECG data to a central ECG cardiovascular information system is optional. The MAC 600 is intended to be used by trained operators in a hospital or medical professional's facility environment as well as used in clinics, physician offices, outreach centers or wherever ECG testing is performed to record ECG signals from surface electrodes.

The MAC 600 Resting ECG Analysis System is intended to perform ECG acquisition, analysis and recording. It can display 3, 6 or 12 leads of ECG data and can print the ECG data 3 leads at a time. The MAC 600 will provide, in resting ECG mode, ECG quality information using the hookup advisor that advises users of poor lead quality based on noise measurement. The MAC 600 can be upgraded to provide software analysis options such as 12-lead interpretive analysis and 12-lead resting ECG measurement and interpretation utilizing the Marquette 12SL ECG Analysis program (K060833). Transmission of ECG data to a central ECG cardiovascular information system is also optional. The MAC 600 delivers multiple leads of ECG on reports and includes a numeric keypad, and function keys for entering patient ID and other data entry. There is an integrated 4.3" color display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data and non-real time reports. The device has removable memory storage to store resting ECG records. The device also can export the resting ECG record to an XML or PDF file on an SD card. The MAC 600 can be run off of a rechargeable lithium-ion battery to allow it to be used as a portable unit.

The GE Healthcare MAC 600 Resting ECG Analysis System did not require a clinical study for substantial equivalence, and therefore the provided document does not contain information regarding acceptance criteria or a study proving the device meets these criteria. The submission focuses on non-clinical tests and demonstrating substantial equivalence to a predicate device.

Specifically, the document states: "The subject of this premarket submission, MAC 600 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information.

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