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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multivariate Vital Signs Index
510(k) Number K240558
Device Name NAVOYCDS
Applicant
Algodx AB
P.O. Box 559173-7985, Visiting Address: Gotgatan 22a
Stockholm,  SE 106 31
Applicant Contact Andreas Macura
Correspondent
Algodx AB
P.O. Box 559173-7985, Visiting Address: Gotgatan 22a
Stockholm,  SE 106 31
Correspondent Contact Andreas Macura
Regulation Number870.2300
Classification Product Code
PLB  
Date Received02/28/2024
Decision Date 07/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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