EZYPRO ECG Recorder (Model: UG02)— 510(k) K213233

Name: FDA 510(k) clearance K213233
Creator: U.S. Food and Drug Administration
Published: 2022-06-23

Substantially Equivalent

Sigknow Biomedical Co., Ltd.

FDA 510(k) clearance K213233 for EZYPRO ECG Recorder (Model: UG02), Substantially Equivalent on 2022-06-23. Applicant: Sigknow Biomedical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sigknow Biomedical Co., Ltd.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2021-09-30
Decision date: 2022-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.