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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
Device Name Everion+ System
Applicant
Biofourmis Singapore Pte. Ltd
2 Venture Drive, Vision Exchange, #07-15
Singapore,  SG 608526
Applicant Contact Milan Shah
Correspondent
Biofourmis
33 Arch Street, 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
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