SONAR-AID(R) ULTRASOUND STANDOFF PAD— 510(k) K874943

Substantially Equivalent

Geistlich-Pharma

FDA 510(k) clearance K874943 for SONAR-AID(R) ULTRASOUND STANDOFF PAD, Substantially Equivalent on 1988-07-25. Applicant: Geistlich-Pharma.

Clearance details

Applicant: Geistlich-Pharma
Product code: Code ITX
Advisory panel: Radiology
Date received: 1987-12-02
Decision date: 1988-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.