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TRAM MODULE

FDA 510(k)

Class II (US FDA 510(k))

510(k) K053121

by GE Healthcare

Identifiers

510(k) Number
K053121 FDA 510(k)
FDA Product Code
MHX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1025 FDA 510(k)
Regulation Number
870.1025 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TRAM MODULE is a physiological monitor with arrhythmia detection or alarms, classified as a Class II device under FDA regulation 870.1025. It is substantially equivalent to a predicate device and was cleared via the FDA 510(k) process under special clearance type. The device is intended for cardiovascular monitoring and is manufactured by GE Healthcare.

The TRAM MODULE is supplied as a new, outright purchase item and includes components such as a label kit and tram 250 amp (250A) configuration. It may be used with accessories like the cable relief kit (TRAM-RAC backplane) and a 3V lithium computer mount disk battery. The device is designed for use in medical equipment settings and is not implantable or sterile.

Frequently asked questions

What is the TRAM MODULE used for?

The TRAM MODULE is intended for cardiovascular monitoring and includes arrhythmia detection or alarms, making it suitable for monitoring patient physiological status in medical equipment settings where cardiac rhythm assessment is needed.

How is the TRAM MODULE supplied and what components does it include?

The TRAM MODULE is supplied as a new, outright purchase item and includes components such as a label kit and tram 250 amp (250A) configuration, and may be used with accessories like the cable relief kit (TRAM-RAC backplane) and a 3V lithium computer mount disk battery.

Is the TRAM MODULE sterile or implantable?

The TRAM MODULE is not implantable or sterile, as it is designed for use in medical equipment settings and is intended for external physiological monitoring rather than surgical implantation or sterile field use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TRAM Module | GE HealthCare Service Shop USA, TRAM | GE HealthCare Service Shop USA, GE HealthCare - Marquette 451 Tram Module - MedWrench, TRAM Module | GE HealthCare Service Shop USA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
GE Healthcare

Sources (1)

  • FDA 510(k) K053121 24 fields · synced Sep 26, 2026