CG-7000DX-BT ECG Recorder/Transmitter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K052556 ↗

FDA Product Code

DXH

FDA applicant

Card Guard Scientific Survival , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.2920

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Card Guard Scientific Survival, Ltd. →

• What is the CG-7000DX-BT ECG Recorder/Transmitter used for?

  The CG-7000DX-BT is a 12-lead ambulatory electrocardiograph designed to record and wirelessly transmit cardiac electrical activity. It functions as both a portable ECG recorder and a Bluetooth-enabled transmitter, enabling remote monitoring and diagnostic analysis in clinical or home settings. This allows healthcare providers to assess heart rhythms without continuous in-person observation.

• How is the CG-7000DX-BT supplied and intended for use?

  The device is intended for single-use in clinical or home settings, though the specifications do not explicitly confirm sterility requirements. It is supplied as a portable unit equipped with recording circuitry, a graphic LCD display, and Bluetooth technology for data transfer. Users attach electrodes to the patient’s chest to capture ECG readings, which are then transmitted wirelessly for review.

• Is the CG-7000DX-BT reusable or single-use?

  The device is explicitly designed for single-use, meaning it is intended to be used once and then discarded. This aligns with typical practices for ambulatory ECG recorders to ensure patient safety, hygiene, and data integrity. Reuse is not recommended based on the manufacturer’s specifications.

• What distinguishes the CG-7000DX-BT from other ECG recorders?

  The CG-7000DX-BT stands out due to its Bluetooth-enabled wireless transmission, allowing real-time or near-real-time ECG data transfer without physical cables. Unlike traditional ECG recorders that require manual data download, this model simplifies remote monitoring by enabling seamless communication between the device and diagnostic systems. It also maintains a 12-lead recording capability for comprehensive cardiac assessment.

• How should the CG-7000DX-BT be stored before use?

  While specific storage instructions are not detailed in the provided data, standard practices for portable medical devices recommend storing the CG-7000DX-BT in a clean, dry environment protected from extreme temperatures, moisture, and physical damage. Ensure the device is kept in its original packaging or a sealed container until ready for use to maintain functionality and hygiene. Avoid exposure to direct sunlight or electromagnetic interference.