CARDIO 7— 510(k) K113306

Name: FDA 510(k) clearance K113306
Creator: U.S. Food and Drug Administration
Published: 2012-07-16

Substantially Equivalent

Bionet Co., Ltd.

FDA 510(k) clearance K113306 for CARDIO 7, Substantially Equivalent on 2012-07-16. Applicant: Bionet Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bionet Co., Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2011-11-09
Decision date: 2012-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.