CT 100 Electrocardiograph

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

510(k) Number

K981951 ↗

FDA Product Code

DPS

Device Class

Class II

Regulation

21 CFR Part 870.2340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• CT 200 Electrocardiograph

  Class II

  FDA 510(k) K961798 Active Cleared 5 Aug 1998

• Is the CT 100 Electrocardiograph designed for single-use or reusable in clinical settings, and what does that mean for maintenance and cleaning?

  The CT 100 Electrocardiograph is explicitly supplied as a reusable medical instrument, meaning it is built for repeated use in clinical or portable environments. Since it is not sterile by design, proper cleaning and disinfection protocols must be followed between patients to prevent cross-contamination. The manufacturer recommends adhering to standard medical device maintenance guidelines for reusable diagnostic equipment, which typically include regular calibration, part inspections, and adherence to manufacturer instructions for sanitization.

• What types of cardiac assessments can the CT 100 Electrocardiograph perform, and how does its portability benefit healthcare providers?

  The CT 100 Electrocardiograph records electrical activity of the heart, producing diagnostic tracings that help healthcare professionals evaluate heart rhythm, rate, and conduction abnormalities. Its compact and lightweight design, combined with long battery life, makes it ideal for both clinical and portable use—such as in ambulances, field hospitals, or remote locations where traditional ECG machines may be impractical. This portability ensures real-time cardiac monitoring in diverse settings without sacrificing diagnostic accuracy.

• How is the CT 100 Electrocardiograph regulated, and what does the FDA’s traditional review process entail for this device?

  The CT 100 Electrocardiograph received FDA 510(k) clearance (K981951) under the traditional review process, which means its safety and performance were compared to a legally marketed predicate device (determined to be *substantially equivalent*). This route involves a detailed submission reviewed by the FDA’s Cardiovascular (CV) Advisory Committee, ensuring compliance with electrocardiograph standards (product code DPS). The traditional review does not imply expedited approval but confirms the device meets established benchmarks for diagnostic ECG functionality.

• Are there any special storage requirements for the CT 100 Electrocardiograph, and how should it be handled to ensure optimal performance?

  While the device lacks specific sterility requirements (as it is reusable), it must be stored and handled according to standard medical device protocols for reusable diagnostic equipment. This includes protecting it from physical damage, extreme temperatures, and moisture to preserve functionality. The manufacturer’s instructions should be consulted for details on calibration, battery maintenance, and environmental conditions (e.g., avoiding direct sunlight or excessive humidity) to ensure long-term reliability and accurate ECG readings.