MONITOR, MODEL 2817— 510(k) K902334

Name: FDA 510(k) clearance K902334
Creator: U.S. Food and Drug Administration
Published: 1990-06-26

Substantially Equivalent

Esaote Biomedica Spa

FDA 510(k) clearance K902334 for MONITOR, MODEL 2817, Substantially Equivalent on 1990-06-26. Applicant: Esaote Biomedica Spa. Device class: 2.

Clearance details

Applicant: Esaote Biomedica Spa
Product code: Code DXJ
Device class: Class 2
Regulation: 21 CFR 870.2450
Advisory panel: Cardiovascular
Date received: 1990-05-24
Decision date: 1990-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.