Model M1403A Telemetry Monitoring Systems (TMS)

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

510(k) Number

K913533 ↗

FDA Product Code

DXH

Device Class

Class II

Regulation

21 CFR Part 870.2920

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Model M1403A Telemetry Monitoring System used for?

  The Model M1403A Telemetry Monitoring System is intended for cardiovascular monitoring applications, functioning as a transmitter and receiver, electrocardiograph, and telephone device to support patient cardiac activity monitoring in clinical settings.

• Is the Model M1403A Telemetry Monitoring System sterile or single-use?

  The device is supplied as a non-sterile, reusable system, meaning it is designed for multiple uses after appropriate cleaning and disinfection, and is not provided in a sterile condition nor intended for single-use disposal.

• How was the Model M1403A Telemetry Monitoring System cleared for market?

  The Model M1403A received FDA 510(k) clearance on November 7, 1991, under submission K913533, through a traditional review process, demonstrating substantial equivalence to a legally marketed predicate device.