Is QardioArm clinically validated?

QardioArm is a regulated medical device: FDA cleared, European CE marked, Canadian CE marked, and Australian TGA cleared.

 

You can find the 501(k) Summary of Safety and Effectiveness for QardioArm here.

 

QardioArm is a highly accurate blood pressure monitor and has undergone independent, formal clinical validation according to ANSI/AAMI/ISO 81060-1:2007, ANSI/AAMI/ISO 81060-2:2009, ANSI/AAMI/IEC 80601-2-30:2009, as well as British Standard EN 1060-4:2004.

 

QardioArm has been validated to meet the ESH - International Protocol Revision 2010 as confirmed on the DABL website here.

 

You can find a direct link to the ESH - International Protocol Revision 2010 validation paper here: Validation of the QardioArm

  

QardioArm is also listed as a validated blood pressure monitor by the British Hypertension Society: Validated BP monitors

 

Learn more about QardioArm accuracy here.

Learn more about QardioArm blood pressure monitor.

 

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