COMPANION 50 REGULATOR/FLOWMETER

K872443 · Puritan Bennett Corp. · DRT · Jul 21, 1987 · Cardiovascular

Device Facts

Record IDK872443
Device NameCOMPANION 50 REGULATOR/FLOWMETER
ApplicantPuritan Bennett Corp.
Product CodeDRT · Cardiovascular
Decision DateJul 21, 1987
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.

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