QardioArm 2

System, Measurement, Blood-pressure, Non-invasive

Qardio Inc

The following data is part of a premarket notification filed by Qardio Inc with the FDA for Qardioarm 2.

Pre-market Notification Details

Device IDK220106
510k NumberK220106
Device Name:QardioArm 2
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Qardio Inc 345 California Street, Suite 600 & 700 San Francisco,  CA  94104
ContactRosario Iannella
CorrespondentRosario Iannella
Qardio Inc 345 California Street, Suite 600 & 700 San Francisco,  CA  94104
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-12
Decision Date2022-06-15

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