CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION— 510(k) K031638

Substantially Equivalent

Electromed Imaging, Inc.

FDA 510(k) clearance K031638 for CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION, Substantially Equivalent on 2003-07-21. Applicant: Electromed Imaging, Inc..

Clearance details

Applicant: Electromed Imaging, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2003-05-27
Decision date: 2003-07-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Laval, Quebec, CA

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.