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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 Drive
Singapore,  SG 608526
Applicant Contact Kuldeep Singh Rajput
Correspondent
Daniel & Daniel Consulting, LLC
340 Jones Lane
Gardnerville,  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
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