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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 K183282
Device Name Biovitals Analytics Engine
Applicant
Biofourmis Singapore Pte. Ltd
Vision Exchange, #07-15, 2 Venture Drive
singapore,  SG 608526
Applicant Contact kuldeep singh rajput
Correspondent
Rakesh Lal
7 Courtyard Pl
lexington,  MA  02420
Correspondent Contact rakesh lal
Regulation Number870.2300
Classification Product Code
PLB  
Date Received11/26/2018
Decision Date 08/15/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT02391987
NCT03661606
Reviewed by Third Party No
Combination Product No
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