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K Number
K012263
Device Name
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
Manufacturer
NATIONAL CUSTOM ENT., INC.
Date Cleared
2001-10-10

(84 days)

Product Code
DPS
Regulation Number
870.2340
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Replacement battery pack for MARQUETTE EAGLE MONITOR MODEL 4000 This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Device Description

Replacement battery pack for MARQUETTE EAGLE MONITOR MODEL 4000

AI/ML Overview

This document is an FDA 510(k) clearance letter for a replacement battery pack for a Marquette Eagle Monitor. It does not contain any information about acceptance criteria, device performance, study details, or ground truth related to an AI/ML powered device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval for a replacement part, not the performance of an AI system.

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).