Life-Watch Monitor LT-8

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

510(k) Number

K863534 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K000137 Active Cleared 17 Apr 2000

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• What clinical environments is the Life-Watch Monitor LT-8 intended for use in, and how does it function there?

  The Life-Watch Monitor LT-8 is designed for use in clinical settings such as hospitals and physician offices. It functions as a standalone cardiac monitor, continuously assessing and displaying heart rate data in real-time. The device provides both visual and audible alerts to notify users of abnormal heart rhythms, ensuring immediate attention to potential cardiac irregularities.

• Is the Life-Watch Monitor LT-8 a single-use or reusable device, and what maintenance is required?

  The Life-Watch Monitor LT-8 is a reusable device. Since it is intended for repeated use, it requires proper sterilization and maintenance following the manufacturer’s guidelines to ensure safety and reliability between patient interactions.

• How is the regulatory status of the Life-Watch Monitor LT-8 determined, and what does this mean for its use?

  The Life-Watch Monitor LT-8 has been authorized for use following FDA 510(k) clearance (K863534), meaning it has been deemed substantially equivalent to a legally marketed device. This clearance confirms that the device meets FDA safety and performance standards for its intended use as a cardiac monitor, including cardiotachometer and rate alarm functionality.

• What safety considerations should be taken into account when using the Life-Watch Monitor LT-8 in a clinical setting?

  The Life-Watch Monitor LT-8 operates within standard MRI safety parameters for non-MRI environments, meaning it is safe to use in areas where MRI machines are present but not actively scanning. However, it is not designed for use inside an MRI scanner. Always follow manufacturer guidelines for proper sterilization, maintenance, and placement to ensure optimal performance and patient safety.