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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K253059
Device Name Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
Applicant
Tournicare Pty, Ltd.
18 Elliot Ave.
Balwyn,  AU 3103
Applicant Contact Niels van Sparrentak
Correspondent
Donawa Lifescience
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/22/2025
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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