AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB

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 Bluetooth Blood Pressure Monitor, Model: Bpm656zb.

Pre-market Notification Details

Device IDK072137
510k NumberK072137
Device Name:AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB
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 Received2007-08-02
Decision Date2007-12-07
Summary:summary

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