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510(k) K213233

EZYPRO ECG Recorder (Model: UG02) by Sigknow Biomedical Co., Ltd. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2022
Date Received
September 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

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