BPFONE, MODEL UA 767IT

K010751 · Medical Monitors Pty Limited · DXN · Jun 11, 2001 · Cardiovascular

Device Facts

Record IDK010751
Device NameBPFONE, MODEL UA 767IT
ApplicantMedical Monitors Pty Limited
Product CodeDXN · Cardiovascular
Decision DateJun 11, 2001
DecisionSESE
Submission TypeAbbreviated
Regulation21 CFR 870.1130
Device ClassClass 2

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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