PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202— 510(k) K100919

Substantially Equivalent

B-K Medical Aps

FDA 510(k) clearance K100919 for PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202, Substantially Equivalent on 2011-12-16. Applicant: B-K Medical Aps.

Clearance details

Applicant: B-K Medical Aps
Product code: Code IYN
Advisory panel: Radiology
Date received: 2010-04-02
Decision date: 2011-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herlev, DK

Download summary PDF View on FDA.gov ↗

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.