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This device is intended for use as a patient monitor for any patient undergoing ECG ST Segment Analysis and/or ECG Stress Analysis during resting or exercise. Exercise can be performed during treadmill or bicycle ergometer use.

This device is capable of performing automatic computerized ECG Interpretation during resting condition. This device does not support automatic ECG Interpretation for neonatal use.

The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.

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The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) clearance letter from the FDA for the QRS Card™ S-T Segment Analysis Patient Monitoring System III.

This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. However, it does not include the detailed performance data, study design, or acceptance criteria that would typically be part of a submission's technical documentation.

Therefore, I cannot provide the requested information from this document.

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