ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202— 510(k) K081154

Substantially Equivalent

B-K Medical Aps

FDA 510(k) clearance K081154 for ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202, Substantially Equivalent on 2008-05-23. Applicant: B-K Medical Aps.

Clearance details

Applicant: B-K Medical Aps
Product code: Code IYO
Advisory panel: Radiology
Date received: 2008-04-23
Decision date: 2008-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Herlev, 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.