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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K163694
Device Name Rooti Rx ECG Event Recorder, Rooti Link APP Software
Applicant
Rooti Labs Ltd.
5F-1, No.17, Zhouzi St., Neihu Dist.
Taipei,  TW 11493
Applicant Contact Sue Chuang
Correspondent
Rooti Labs Ltd.
5F-1, No.17, Zhouzi St., Neihu Dist.
Taipei,  TW 11493
Correspondent Contact Sue Chuang
Regulation Number870.2910
Classification Product Code
DRG  
Date Received12/28/2016
Decision Date 11/07/2017
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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