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Cardiac Monitor 1500

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191697

by Zynex Medical, Inc.

Identifiers

510(k) Number
K191697 FDA 510(k)
FDA Product Code
DSB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2770 FDA 510(k)
Regulation Number
870.2770 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cardiac Monitor 1500 is a plethysmograph, impedance device classified as a cardiovascular monitoring system. It functions as a non-invasive monitor that continuously tracks bioelectrical impedance, heart rate, ECG amplitude, PPG amplitude, and skin temperature, providing real-time numerical values and trending data.

It is supplied as a standalone desktop monitor intended for use in professional medical environments such as hospitals, clinics, and research settings. The device is authorized under FDA 510(k) clearance K191697 and is classified as a Class II medical device under regulation number 870.2770.

Frequently asked questions

What is the Cardiac Monitor 1500 used for?

The Cardiac Monitor 1500 is used as a non-invasive monitor to continuously track bioelectrical impedance, heart rate, ECG amplitude, PPG amplitude, and skin temperature, providing real-time numerical values and trending data for cardiovascular monitoring in professional medical settings.

How is the Cardiac Monitor 1500 supplied and where is it intended for use?

The Cardiac Monitor 1500 is supplied as a standalone desktop monitor intended for use in professional medical environments such as hospitals, clinics, and research settings, where continuous non-invasive cardiovascular monitoring is required.

What regulatory authorization does the Cardiac Monitor 1500 have?

The Cardiac Monitor 1500 is authorized under FDA 510(k) clearance K191697 and is classified as a Class II medical device under regulation number 870.2770, indicating it was found substantially equivalent to a legally marketed 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: Cardiac Monitor 1500 510 (k) FDA Premarket Notification K191697 Zynex ..., Cardiac Monitor 1500 (K191697) — FDA 510 (k) | Innolitics, Zynex Monitoring Solutions - medical devices

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zynex Medical, Inc.

Sources (1)

  • FDA 510(k) K191697 24 fields · synced Sep 24, 2026