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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 K260693
Device Name VicorderCS (VCS-SYS-1100)
Applicant
80 Beats Medical GmbH
Kantstr 105
Berlin,  DE 10627
Applicant Contact Arnd Warmuth
Correspondent
Marcella Garcia
249 Fox Hill Rd.
Burlington,  MA  01803
Correspondent Contact Marcella Garcia
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/03/2026
Decision Date 06/16/2026
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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