MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR— 510(k) K925411

Substantially Equivalent

Accucore, Inc.

FDA 510(k) clearance K925411 for MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR, Substantially Equivalent on 1993-02-25. Applicant: Accucore, Inc..

Clearance details

Applicant: Accucore, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1992-10-26
Decision date: 1993-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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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.