ZURA TEE SYSTEM— 510(k) K080223

Substantially Equivalent

Imacor, LLC

FDA 510(k) clearance K080223 for ZURA TEE SYSTEM, Substantially Equivalent on 2008-06-24. Applicant: Imacor, LLC.

Clearance details

Applicant: Imacor, LLC
Product code: Code IYO
Advisory panel: Radiology
Date received: 2008-01-29
Decision date: 2008-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.