ULTRASOUND SCANNER, TYPE 2102— 510(k) K011417

Substantially Equivalent

B-K Medical A/S

FDA 510(k) clearance K011417 for ULTRASOUND SCANNER, TYPE 2102, Substantially Equivalent on 2001-06-08. Applicant: B-K Medical A/S.

Clearance details

Applicant: B-K Medical A/S
Product code: Code IYO
Advisory panel: Radiology
Date received: 2001-05-09
Decision date: 2001-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gentofte, DK

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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.