DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED— 510(k) K914945

Substantially Equivalent

Bruel & Kjaer Industri A/S

FDA 510(k) clearance K914945 for DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED, Substantially Equivalent on 1992-06-26. Applicant: Bruel & Kjaer Industri A/S.

Clearance details

Applicant: Bruel & Kjaer Industri A/S
Product code: Code IYO
Advisory panel: Radiology
Date received: 1991-11-04
Decision date: 1992-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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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.