DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325— 510(k) K100565

Substantially Equivalent

Bio-Detek, Inc.

FDA 510(k) clearance K100565 for DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325, Substantially Equivalent on 2010-11-16. Applicant: Bio-Detek, Inc..

Clearance details

Applicant: Bio-Detek, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2010-03-01
Decision date: 2010-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pawtucket, RI, US

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Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.