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QUIKPAGE Arrhythmia Report Generator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K841083

by Agilent Technologies

Identifiers

510(k) Number
K841083 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 QUIKPAGE Arrhythmia Report Generator is a software-based device classified as a detector and alarm for arrhythmia. It is designed to automatically generate clinical reports from arrhythmia detection data, aiding in the documentation and analysis of cardiac events.

This device is intended for use in clinical settings where arrhythmia monitoring data needs to be compiled into structured reports. It operates as a single-use software tool, is not MRI safe, and does not require sterile handling. The device was authorized via FDA 510(k) premarket notification under regulation number 870.1025, product code DSI, and is associated with cardiovascular advisory committee review.

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: QUIKPAGE ARRHYTHMIA REPORT GENERATOR (K841083) — FDA 510 (k) | Innolitics, Quikpage Arrhythmia Report Generator 510 (k) FDA Premarket Notification ..., Agilent Technologies FDA 510 (k) Products (1982-2001), XF Real-Time ATP Rate Assay Report Generator | Agilent, PDF Seahorse XF Real-Time ATP Rate Assay Report Generator User Guide - Agilent

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Agilent Technologies

Sources (1)

  • FDA 510(k) K841083 24 fields · synced Sep 24, 2026