ULTRASOUND SCANNER MINI FOCUS, MODEL 1402— 510(k) K043554

Substantially Equivalent

B-K Medical A/S

FDA 510(k) clearance K043554 for ULTRASOUND SCANNER MINI FOCUS, MODEL 1402, Substantially Equivalent on 2005-01-14. Applicant: B-K Medical A/S.

Clearance details

Applicant: B-K Medical A/S
Product code: Code IYN
Advisory panel: Radiology
Date received: 2004-12-27
Decision date: 2005-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Herlev, 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.