ULTRASOUND SCANNER TYPE 2101— 510(k) K003041

Substantially Equivalent

B-K Medical A/S

FDA 510(k) clearance K003041 for ULTRASOUND SCANNER TYPE 2101, Substantially Equivalent on 2001-02-07. Applicant: B-K Medical A/S.

Clearance details

Applicant: B-K Medical A/S
Product code: Code IYO
Advisory panel: Radiology
Date received: 2000-09-29
Decision date: 2001-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gentofte, 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.