Ultrasound System 1300— 510(k) K231764

Substantially Equivalent

Bk Medical Aps

FDA 510(k) clearance K231764 for Ultrasound System 1300, Substantially Equivalent on 2023-10-23. Applicant: Bk Medical Aps.

Clearance details

Applicant: Bk Medical Aps
Product code: Code IYN
Advisory panel: Radiology
Date received: 2023-06-16
Decision date: 2023-10-23
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.