POISE DATAENGINE— 510(k) K040969

Substantially Equivalent

Poise Technology Corporation

FDA 510(k) clearance K040969 for POISE DATAENGINE, Substantially Equivalent on 2004-06-08. Applicant: Poise Technology Corporation.

Clearance details

Applicant: Poise Technology Corporation
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2004-04-14
Decision date: 2004-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.