BIFOCAL 3.0MHZ— 510(k) K833224

Substantially Equivalent

Adr Ultrasound

FDA 510(k) clearance K833224 for BIFOCAL 3.0MHZ, Substantially Equivalent on 1983-11-29. Applicant: Adr Ultrasound.

Clearance details

Applicant: Adr Ultrasound
Product code: Code ITX
Advisory panel: Radiology
Date received: 1983-09-06
Decision date: 1983-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.