AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849— 510(k) K852502

Substantially Equivalent

Bruel & Kjaer Industri A/S

FDA 510(k) clearance K852502 for AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849, Substantially Equivalent on 1986-10-23. Applicant: Bruel & Kjaer Industri A/S.

Clearance details

Applicant: Bruel & Kjaer Industri A/S
Product code: Code IYO
Advisory panel: Radiology
Date received: 1985-06-12
Decision date: 1986-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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.