K152305

Substantially Equivalent

Nihon Kohden Afib Detection Program QP-039P

Applicant: Nihon Kohden Corporation
Product code: DSI
Advisory panel: Cardiovascular
Date received: 2015-08-14
Decision date: 2016-04-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tokyo, JP

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.