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12-Lead electrocardiograph capable of recording and transmitting up to 40 standard ECGs for the purpose of cardiac monitoring and diagnosis, incorporates recording/ transmitting circuitry, graphic LCD, a package of firmware tools and is intended for use by a medical professional:
a. The ECG is recorded and transmitted to a remote receiving station for consultation with a cardiologist.
b. The ECG is recorded and transferred to a remote hand held device/PC/printer for viewing and processing.

The CG-7000DX-BT ECG Recorder/Transmitter is a 12 Lead ambulatory electrocardiograph capable of recording and transmitting up to 40 standard FCGs for the purpose of cardize monitoring and diagnosis. The device incorporates a recording and transmitting circuitry. graphic LCD, a package of firmware tools. The BT module (Tiden-Yuden Ltd.) conveys data to a remote hand held receiving device/PC or laser/Ink-jet printer.

This submission is a 510(k) summary for the CG-7000DX-BT ECG Recorder/Transmitter, a Class II medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information from the provided text. The document specifically states: "No performance standards have been developed under Section 514 of the Federal Food, Drug and Cosmetic Art for telephone ECG transmitter devices." This indicates that the regulatory pathway for this device did not require a study to prove acceptance criteria against specific performance standards, but rather a demonstration of substantial equivalence to an already legally marketed device.

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