MCKESSON HORIZON CARDIOLOGY— 510(k) K112720

Substantially Equivalent

Mckesson Israel , Ltd.

FDA 510(k) clearance K112720 for MCKESSON HORIZON CARDIOLOGY, Substantially Equivalent on 2012-01-30. Applicant: Mckesson Israel , Ltd..

Clearance details

Applicant: Mckesson Israel , Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2011-09-19
Decision date: 2012-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

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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.