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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 K213233
Device Name EZYPRO ECG Recorder (Model: UG02)
Applicant
Sigknow Biomedical Co., Ltd.
6f., # 760, Sec. 4, Bade Rd., Songshan Dist,
Taipei City,  TW 105412
Applicant Contact Hsiao-Fan Liu
Correspondent
Sigknow Biomedical Co., Ltd.
6f., # 760, Sec. 4, Bade Rd., Songshan Dist,
Taipei City,  TW 105412
Correspondent Contact Hsiao-Fan Liu
Regulation Number870.2910
Classification Product Code
DRG  
Date Received09/30/2021
Decision Date 06/23/2022
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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