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

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.

Clearance details

Applicant: Esaote Biomedica Spa
Product code: Code IYO
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 ↗

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.