QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)— 510(k) K093172

Substantially Equivalent

Dynacardia, Inc.

FDA 510(k) clearance K093172 for QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000), Substantially Equivalent on 2010-01-20. Applicant: Dynacardia, Inc..

Clearance details

Applicant: Dynacardia, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2009-10-08
Decision date: 2010-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Azusa, CA, US

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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.