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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K182344
Device Name RhythmAnalytics
Applicant
Biofourmis Singapore Pte., Ltd.
Vision Exchange, #07-15, 2 Venture Dr.
Singapore,  SG 608526
Applicant Contact Kuldeep Singh Rajput
Correspondent
Daniel & Daniel Consulting, LLC
340 Jones Lane
Gerdnerville,  NV  89460
Correspondent Contact Michael Daniel
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DPS  
Date Received08/28/2018
Decision Date 03/07/2019
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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