ARRYTHMIA PRINTER OPTION— 510(k) K811792

Name: FDA 510(k) clearance K811792
Creator: U.S. Food and Drug Administration
Published: 1981-07-10

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K811792 for ARRYTHMIA PRINTER OPTION, Substantially Equivalent on 1981-07-10. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1981-06-24
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.