EMM Ultrasonic Transducer Cover— 510(k) K211969

Substantially Equivalent

Exact Medical Manufacturing

FDA 510(k) clearance K211969 for EMM Ultrasonic Transducer Cover, Substantially Equivalent on 2021-08-13. Applicant: Exact Medical Manufacturing.

Clearance details

Applicant: Exact Medical Manufacturing
Product code: Code ITX
Advisory panel: Radiology
Date received: 2021-06-24
Decision date: 2021-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancaster, NY, 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.