PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA— 510(k) K901032

Substantially Equivalent

Accucore, Inc.

FDA 510(k) clearance K901032 for PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA, Substantially Equivalent on 1990-04-04. Applicant: Accucore, Inc..

Clearance details

Applicant: Accucore, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1990-03-06
Decision date: 1990-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.