HORIZON CENTRAL STATION

K892066 · Mennen Medical, Inc. · DRT · Jun 22, 1989 · Cardiovascular

Device Facts

Record IDK892066
Device NameHORIZON CENTRAL STATION
ApplicantMennen Medical, Inc.
Product CodeDRT · Cardiovascular
Decision DateJun 22, 1989
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.2300
Device ClassClass 2

Regulatory Classification

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.

Innolitics

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