SAFERSONIC SONOGRAPHY COVER— 510(k) K092858

Substantially Equivalent

Safersonic Medizinprodukte GmbH

FDA 510(k) clearance K092858 for SAFERSONIC SONOGRAPHY COVER, Substantially Equivalent on 2009-11-10. Applicant: Safersonic Medizinprodukte GmbH.

Clearance details

Applicant: Safersonic Medizinprodukte GmbH
Product code: Code ITX
Advisory panel: Radiology
Date received: 2009-09-16
Decision date: 2009-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.