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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
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