DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535— 510(k) K905198

Substantially Equivalent

Bruel & Kjaer

FDA 510(k) clearance K905198 for DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, Substantially Equivalent on 1991-08-28. Applicant: Bruel & Kjaer.

Clearance details

Applicant: Bruel & Kjaer
Product code: Code IYN
Advisory panel: Radiology
Date received: 1990-11-20
Decision date: 1991-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naerum 2850, DK

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.