AVITA ARM TYPE BLOOD PRESSURE MONITOR

System, Measurement, Blood-pressure, Non-invasive

AVITA CORPORATION

The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Arm Type Blood Pressure Monitor.

Pre-market Notification Details

Device IDK112825
510k NumberK112825
Device Name:AVITA ARM TYPE BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant AVITA CORPORATION 2904 N. BOLDT DR. Flagstaff,  AZ  86001
ContactJennifer Reich
CorrespondentJennifer Reich
AVITA CORPORATION 2904 N. BOLDT DR. Flagstaff,  AZ  86001
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-28
Decision Date2012-01-18

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