NOVATRANS II

K951129 · Medex, Inc. · DRS · Apr 5, 1995 · Cardiovascular

Device Facts

Record IDK951129
Device NameNOVATRANS II
ApplicantMedex, Inc.
Product CodeDRS · Cardiovascular
Decision DateApr 5, 1995
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.2850
Device ClassClass 2

Regulatory Classification

Identification

An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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