510(k) K151702— Reusable Full Silicone Cover

Substantially Equivalent

Laerdal Medical AS

Clearance details

Applicant: Laerdal Medical AS
Product code: Code LIX
Advisory panel: Cardiovascular
Date received: 2015-06-24
Decision date: 2015-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Stavanger, NO

Adverse events under product code LIX

product code LIX

Other: 2
Total: 2

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.