ECG MiniMonitor, Model CG-5000

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

510(k) Number

K992696 ↗

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. →

• Can this ECG MiniMonitor transmit ECG data remotely, and if so, how does it do that?

  Yes, the ECG MiniMonitor, Model CG-5000 is designed to optionally transmit ECG signals via telephone. This feature allows real-time monitoring of cardiac conditions to be shared remotely, enabling remote analysis and consultation by healthcare providers.

• Is the ECG MiniMonitor, Model CG-5000 intended for single-use or reusable applications, and how should it be handled?

  The device is designed for use in both single-use and reusable clinical settings, depending on facility protocols. While specific sterility or reprocessing instructions are not detailed, standard medical device handling practices should be followed to ensure safety and compliance.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The ECG MiniMonitor, Model CG-5000 received FDA clearance through a 510(k) submission (K992696) under the Traditional clearance type, classified as Substantially Equivalent to a predicate device. It falls under product code DXH and is regulated as a Class II device in the cardiovascular specialty. This means it has undergone FDA review to ensure safety and effectiveness for its intended use as an electrocardiograph transmitter and receiver.

• Does this device come in multiple sizes or models, and if so, how are they differentiated?

  The provided data lists multiple FEI numbers (e.g., 3013689228, 3011265784) associated with the ECG MiniMonitor, Model CG-5000, which may indicate variations in design, configuration, or regulatory filings. However, the data does not specify distinct physical sizes or model variants beyond the single model name (CG-5000). Clarification from the manufacturer would be needed for exact differences.

• What are the standard storage conditions for this device, and are there any special handling requirements?

  The data does not specify detailed storage conditions beyond standard medical device handling. Facilities should follow general guidelines for ECG equipment, such as protecting it from extreme temperatures, humidity, and physical damage. If the device is reusable, additional protocols for cleaning, disinfection, or sterilization (if applicable) should align with facility infection control policies.