ULTRASOUND SCANNER, MODEL TYPE 2101— 510(k) K991937

Substantially Equivalent

B & K Medical A/S

FDA 510(k) clearance K991937 for ULTRASOUND SCANNER, MODEL TYPE 2101, Substantially Equivalent on 1999-07-30. Applicant: B & K Medical A/S.

Clearance details

Applicant: B & K Medical A/S
Product code: Code IYO
Advisory panel: Radiology
Date received: 1999-06-09
Decision date: 1999-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Dk 2820 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.