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K Number
K955045

Validate with FDA (Live)

Device Name
OMNI-TRAK PATIENT MONITORING SYSTEM
Manufacturer
INVIVO RESEARCH, INC.
Date Cleared
1996-07-11

(251 days)

Product Code
DPS
Regulation Number
870.2340
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).