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Mortara Instrument Model Eli-Xr (Treadmill Included)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K880664

by Mortara Instrument, Inc.

Identifiers

510(k) Number
K880664 FDA 510(k)
FDA Product Code
DSI 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 device is a Detector And Alarm, Arrhythmia, as defined in the device data. It is a cardiovascular monitoring system that includes a treadmill component for stress testing applications.

It was cleared through the FDA 510(k) process under K880664, classified as a Class II device with product code DSI. The device is supplied by Mortara Instrument, Inc. and is intended for use in clinical settings where arrhythmia detection and alarm functionality are required during cardiovascular stress testing.

Frequently asked questions

What is the Mortara Instrument Model ELI-XR used for?

The Mortara Instrument Model ELI-XR is a cardiovascular monitoring system designed for arrhythmia detection and alarm functionality during stress testing, incorporating a treadmill component to support cardiovascular stress testing applications in clinical settings.

How is the Mortara Instrument Model ELI-XR supplied and what is its intended use environment?

The device is supplied by Mortara Instrument, Inc. and is intended for use in clinical settings where arrhythmia detection and alarm functionality are required during cardiovascular stress testing, as specified in its FDA 510(k) clearance documentation.

What regulatory pathway was used for the Mortara Instrument Model ELI-XR and what is its classification?

The Mortara Instrument Model ELI-XR was cleared through the FDA 510(k) process under submission K880664, classified as a Class II device with product code DSI, and determined to be substantially equivalent to a predicate device.

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: Mortara Instrument Model Eli-xr (Treadmill Included), PDF K880664 Mortara Instrument Model Eli-xr (Treadmill Included), Mortara Instrument… — 51 FDA 510 (k)s · DeviceClearance, Mortara Instrument Manuals & User Guides - Manuals+, Mortara Instrument Inc FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mortara Instrument, Inc.

Sources (1)

  • FDA 510(k) K880664 24 fields · synced Sep 21, 2026