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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
FOIA Releasable 510(k) 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
Predetermined Change
Control Plan Authorized		 No
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