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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K213863
FOIA Releasable 510(k) K213863
Device Name Everion+ System
Applicant
Biofourmis Singapore Pte., Ltd.
2 Venture Dr., Vision Exchange, #07-15
Singapore,  SG 608526
Applicant Contact Milan Shah
Correspondent
Biofourmis
33 Arch St., Floor# 17
Boston,  MA  02110
Correspondent Contact Nandini Murthy
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
BZQ   MWI  
Date Received12/10/2021
Decision Date 02/23/2023
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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