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K Number
K010732
Device Name
VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
Manufacturer
TELEMEDIC SYSTEMS, INC.
Date Cleared
2001-09-27

(199 days)

Product Code
MWI
Regulation Number
870.2300
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
K073094
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).