CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K— 510(k) K101198

Substantially Equivalent

Computerized Screening, Inc.

FDA 510(k) clearance K101198 for CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K, Substantially Equivalent on 2010-08-04. Applicant: Computerized Screening, Inc..

Clearance details

Applicant: Computerized Screening, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2010-04-29
Decision date: 2010-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.