SONIXGPS— 510(k) K121812

Substantially Equivalent

Ultrasonix Medical Corporation

FDA 510(k) clearance K121812 for SONIXGPS, Substantially Equivalent on 2013-12-02. Applicant: Ultrasonix Medical Corporation.

Clearance details

Applicant: Ultrasonix Medical Corporation
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2012-06-20
Decision date: 2013-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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.