AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM— 510(k) K896356

Name: FDA 510(k) clearance K896356
Creator: U.S. Food and Drug Administration
Published: 1990-08-21

Substantially Equivalent

Esaote Biomedica Spa

FDA 510(k) clearance K896356 for AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM, Substantially Equivalent on 1990-08-21. Applicant: Esaote Biomedica Spa. Device class: 2.

Clearance details

Applicant: Esaote Biomedica Spa
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1989-11-06
Decision date: 1990-08-21
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 IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.