CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM— 510(k) K002604

Substantially Equivalent

Invivo Research, Inc.

FDA 510(k) clearance K002604 for CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM, Substantially Equivalent on 2002-02-07. Applicant: Invivo Research, Inc..

Clearance details

Applicant: Invivo Research, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2000-08-22
Decision date: 2002-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.